Aim: This study was conducted to assess the safety and efficacy of postoperative hypofractionated... more Aim: This study was conducted to assess the safety and efficacy of postoperative hypofractionated radiotherapy (HRT) using simultaneous integrated boost (SIB) technique for glioblastoma (GBM) compared to conventional radiotherapy (CRT). Study Design: This was a prospective study with historical control arm. Place and Duration of the Study: Department of Clinical Oncology and Nuclear Medicine, Mansoura University Hospital, Mansoura, Egypt, between May 2017 and June 2019. Methods: The intervention (HRT) group included 30 patients who received 3D conformal HRT with SIB using field in field (FIF) technique to deliver a differential radiation dose to different targets. Planning target volume 60 (PTV60) includes the gross target volume (GTV) plus a 5-mm margin, and PTV45 includes the GTV plus a 15-mm margin. PTV60 will receive 60 Gy in 20 fractions, and PTV45 will receive 45 Gy in the same 20 fractions (one fraction daily and 5 days per week).The CRT group included 30 patients who receive...
Background: Small cell lung cancer (SCLC) is a high grade neuroendocrine tumor, and has aggressiv... more Background: Small cell lung cancer (SCLC) is a high grade neuroendocrine tumor, and has aggressive nature, so the majority of cases are presented with extensive disease. SCLC was staged into 2 categories: limited-stage disease (LS-SCLC) and extensive disease (ES-SCLC). Despite SCLC is sensitive to radiotherapy and chemotherapy, SCLC has high tendency for rapid dissemination to regional and distant sites. Median survival time ranged from 2-4 months in patients with untreated SCLC. Multiagent chemotherapy was the primary treatment for SCLC. Aim of the work: This retrospective study was conducted to evaluate and analyze clinical features, treatment outcome, survival and prognostic factors affecting survival in patients with SCLC presented to Clinical Oncology and Nuclear Medicine department, Chest department and Medical oncology unit in Mansoura Oncology Centre during the period from 2000-2015. Methods: Data of patients were collected from their files. The information obtained included demographic features, treatment received; its toxicity and outcome, survival and its prognostic factors. Demographic data were: age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), smoking status, stage of disease. Data also included disease presentation and metastatic sites. Several factors affecting survival were analysed as age, sex, stage, PS, smoking status and LDH. Results: Sixty-three patients were enrolled in this study. Median age was 56.2 ± 6. Strong male predominance (92.1%) was observed; 84.1% of them were smoker. Thirty six patients (57.2%) were of ECOG-PS of 0-1. ES-SCLC was reported in 65% of cases and LDH was high (>1.5 xN) in 47.6%. The most common symptom was chest pain (38.1%) followed by cough (31.8%), weight loss (30%). Fifteen patients had single metastatic site (23.8%
Medical oncology (Northwood, London, England), 2012
Due to socioeconomic issues, locally advanced breast cancer (LABC) is still a common presentation... more Due to socioeconomic issues, locally advanced breast cancer (LABC) is still a common presentation of breast cancer in the third world. It was found that LABC patients showing a clinical response after two to four cycles of neoadjuvant chemotherapy have a higher probability of obtaining a pathological complete response at surgery than patients without an early response. In the present work, the short-term effects and toxicity of the neoadjuvant second-line vinorelbine and gemcitabine combination were evaluated in the treatment of LABC who did not show early response to anthracyclines and taxanes-containing regimen. The use of vinorelbine and gemcitabine was based on their use in metastatic breast cancer cases who had been treated before with anthracyclines and taxanes. This was a prospective phase II study accomplished at the Clinical Oncology and Nuclear Medicine Department of Mansoura University, Egypt. Seventy LABC patients not suitable for breast conservative surgery who failed t...
Triple-negative breast cancer (TNBC) is diagnosed more frequently in younger and premenopausal wo... more Triple-negative breast cancer (TNBC) is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American women. TNBC is a term derived from tumors that are characterized by the absence of ER, PgR, and HER2. So patients with TNBC do not benefit from hormonal or trastuzumab-based therapies. TNBCs are biologically aggressive, although some reports suggest that they respond to chemotherapy better than other types of breast cancer, prognosis remains poor. This is due to: shortened disease-free interval in the adjuvant and neoadjuvant setting and a more aggressive course in the metastatic setting.
American Journal of Cancer Therapy and Pharmacology, Feb 21, 2014
Several lines of evidence suggest that it is time to re-examine the approach to the patient diagn... more Several lines of evidence suggest that it is time to re-examine the approach to the patient diagnosed with distant metastases at the initial breast cancer presentation.
Clinical Oncology and Cancer Research, Sep 1, 2011
Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas ha... more Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas has been reported with gemcitabine and/or docetaxel. METHODS Forty patients with advanced soft tissue sarcomas refractory to first-line chemotherapy treatment were enrolled. They received combination of gemcitabine at dose of 900 mg/m 2 on days 1 and 8 and docetaxel at dose of 100 mg/m 2 on day 8, and had this regimen repeated every 3 weeks. If the patients had received the pelvic irradiation in advance, gemcitabine dose was reduced to 675 mg/m 2 on days 1 and 8 and docetaxel to 75 mg/m 2 on day 8, and had it repeated every 3 weeks.
The Chinese German Journal of Clinical Oncology, Aug 1, 2011
Abstract Objective Despite resection with curative intent, a majority of patients with gastric ca... more Abstract Objective Despite resection with curative intent, a majority of patients with gastric cancer will develop disease recurrence. Postoperative adjuvant chemo-radiotherapy increase the curability of surgery, prevent local recurrence and improve survival. Methods ...
Medical oncology (Northwood, London, England), 2012
A phase II trial of irinotecan and cisplatin (IP) as induction chemotherapy followed by conventio... more A phase II trial of irinotecan and cisplatin (IP) as induction chemotherapy followed by conventional thoracic irradiation concurrent with low-dose weekly cisplatin for limited-disease small-cell lung cancer (LDS-SCLC). Between February 2005 and December 2008, 34 chemotherapy-naïve patients with LD-SCLC were enrolled. Treatment consisted of two 21-day cycles of cisplatin 40 mg/m(2) and irinotecan 80 mg/m(2) intravenously (IV) on days 1 and 8 followed by conventional thoracic irradiation at a dose of 54 Gy concurrent with cisplatin at dose of 20 mg/m(2) weekly then prophylactic cranial irradiation at dose of 30 Gy in 10 fractions for those achieved complete or partial response. Only 33 patients received the treatment protocol, and they were assessed for response and toxicity. After induction chemotherapy, overall response rate was (72.73%). After median follow-up of 27 months, the median survival was 25 months (95% CI, 21.249-28.751) with 1 and 2-year overall survival rates of 83 and ...
The objective of this study was to evaluate the results of combined chemoradiotherapy using 5-flu... more The objective of this study was to evaluate the results of combined chemoradiotherapy using 5-fluorouracil and cisplatin with radiation in treatment of anal squamous cell carcinoma in terms of local control, survival, and toxicity. This study included 32 patients with histologically confirmed locally advanced anal squamous cell carcinoma (T1-4 with any N). They received chemotherapy consisted of 5-fluorouracil 1000 mg/m(2)/day on the first 5 and last 5 days of RT, cisplatin 75 mg/m(2) on days 2 and 30. External beam RT consisted of 45Gy/f/25 sessions/5 sessions per week. A boost of 9Gy/5 sessions was given to those who developed complete or partial response. Median age was 55 years with female to male ratio 2.2:1. Fifty-six percent of them had ECOGPS of 1; moderately differentiated pathology was the most common one (53 %). Thirteen patients (40.6 %) presented with N0 and 56 % presented with T2. None of the patients died of acute complications and none developed grade 4 toxicity. Non-hematological complications were more common than hematological ones. Dermatitis was the most common toxicity (59.3 %) than diarrhea and neurologic one (40.7 %). Anemia was the most frequent hematological adverse event (37.5 %). Complete response was reported in 81.2 %. After median follow-up of 25 months, local recurrence was observed in five patients (15.6 %) as the following: three in the anal canal and two in the inguinal lymph nodes. Three patients (9.4 %) developed distant metastasis (two in the liver and one in the lung), while one patient (3 %) had both local and distant metastases. Three-year overall survival rate (OS) was 81.3 %, while 3-year progression-free survival (PFS) rate was 72 %, and colostomy-free survival was 90 %. Concomitant chemoradiotherapy of 5-fluorouracil and cisplatin with radiotherapy is a highly effective and well-tolerated treatment of anal cancer. But further studies with larger number of patients are needed to support the indication to treat anal cancer using this regimen.
The Chinese-German Journal of Clinical Oncology, 2011
Abstract Objective Despite resection with curative intent, a majority of patients with gastric ca... more Abstract Objective Despite resection with curative intent, a majority of patients with gastric cancer will develop disease recurrence. Postoperative adjuvant chemo-radiotherapy increase the curability of surgery, prevent local recurrence and improve survival. Methods ...
Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas ha... more Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas has been reported with gemcitabine and/or docetaxel. METHODS Forty patients with advanced soft tissue sarcomas refractory to first-line chemotherapy treatment were enrolled. They received combination of gemcitabine at dose of 900 mg/m 2 on days 1 and 8 and docetaxel at dose of 100 mg/m 2 on day 8, and had this regimen repeated every 3 weeks. If the patients had received the pelvic irradiation in advance, gemcitabine dose was reduced to 675 mg/m 2 on days 1 and 8 and docetaxel to 75 mg/m 2 on day 8, and had it repeated every 3 weeks.
Despite median survival of less than 6 months, there is a significant proportion of advanced panc... more Despite median survival of less than 6 months, there is a significant proportion of advanced pancreatic cancer patients who progress on gemcitabine that remains fit, and these patients are candidates for second-line treatment. The objective of this study is to evaluate the efficacy and safety of oxaliplatin plus 5-fluorouracil and folinic acid in patients with gemcitabine-pretreated advanced pancreatic cancer. Thirty patients with advanced pancreatic cancer who were pretreated with gemcitabine received oxaliplatin (85 mg/m(2)) on days 1 and 15 followed by leucovorin (20 mg/m(2)) and 5-fluorouracil (500 mg/m(2)) on days 1, 8, and 15. The cycle was repeated every 3 weeks. The majority of patients (80 %) had locally advanced disease. Median age was 63 years, and 60 % were males. The liver was the most common site of metastasis. Partial response was observed in 2 patients (6.7 %) and stable disease in 6 patients (20 %), while 12 patients progressed (40 %). Improved performance status was reported in 10 patients (33.3 %). The median duration of response was 13 weeks, and median overall survival was 22 weeks. There was no grade 4 toxicity apart from grade 4 neutropenia in 6.6 % of patients. Neutropenia (46.5 %) and neuropathy (43.2 %) were the most common toxicities, while hand-foot syndrome was the least frequent one (20 %). There were no treatment-related deaths. The 6-month survival rate was 30 %. This regimen is feasible and active with an acceptable toxicity; however, further investigation in phase III trial is needed.
Objective To evaluate toxicity and efficacy of addition of weekly irinotecan to a regimen of chem... more Objective To evaluate toxicity and efficacy of addition of weekly irinotecan to a regimen of chemoradiotherapy of 5fluorouracil with concurrent pelvic radiation in patients with locally advanced rectal cancer. Patients and methods Between October 2006 and December 2009, 36 patients with non-metastatic rectal adenocarcinoma were treated with chemoradiotherapy of irinotecan (50 mg/m 2 weekly), 5-fluorouracil (250 mg/m 2 for 5 days/week) and pelvic radiation (45 Gy/1.8 Gy/fraction for 5 days/week) by 3D conformal radiotherapy. Results All patients completed the planned treatment. After the chemoradiotherapy, overall clinical response rate was 55.5% and pathological complete was 16.7%. Neutropenia was the most common hematologic toxicity (58.3%) with grade III in 5.5% while among non hematologic toxicity, diarrhea was the most common reported one (63.9%) with grade III in 13.9% followed by nausea and vomiting (47.2%). After a median follow-up of 23 months, progression-free and overall survival estimates at 2 years were 72% and 91.7%, respectively. Distant relapses were recoded in 16.7%, the main distant failure sites were lung and liver, and local relapse was found in 5.6%.
The objective of this study was to compare concomitant chemoradiotherapy based on weekly low-dose... more The objective of this study was to compare concomitant chemoradiotherapy based on weekly low-dose gemcitabine versus weekly low-dose paclitaxel in locally advanced head and neck squamous cell carcinoma. Previously, untreated patients with locally advanced squamous cell carcinoma of the head and neck were randomly assigned to one of the two concomitant chemoradiation regimens: (1) weekly gemcitabine at a dose of 100 mg/m(2) over 30 min 1-2 h before radiotherapy and (2) weekly paclitaxal at a dose of 20 mg/m(2) over 60 min 4-6 h before radiotherapy. The planned radiotherapy dose was 65 Gy over 6.5 weeks in 32 settings. Two hundred and sixteen patients were randomly divided into 2 groups: group A (110 patients) and group B (106 patients) who received concomitant weekly low-dose gemcitabine and low-dose paclitaxal, respectively, with the radiotherapy protocol. The hematological toxicity was generally mild. On the contrary, non-hematologic toxicities were severe. Grade III mucositis occurred in 36% in group A and in 24% in group B (P = 0.04). Moreover, grade III dermatitis were encountered in 24% in group A and 13% in group B (P = 0.049). Thirty-two (29%) of group A and 18(17%) of group B patients required enteral or parenteral feeding (P = 0.01). Sixteen (15%) of group A and 6 (6%) of group B required enteral or parenteral feeding that lasted for 6 months (P = 0.03). Regarding the late effect on swallowing, 8% of patients in group A and 2% of patients in group B required enteral or parenteral feeding for more than 6 months (P = 0.035). Response rates were 78 and 89% in groups A and B, respectively (P = 0.038). The 2-year progression-free survival figures were 54 and 64% of groups A and B, respectively; however, the 2-year overall survival figures were 56 and 67%, respectively. On the other hand, the 3-year progression-free survival figures were 39 and 48% for groups A and B, respectively, while the 3-year overall survival figures were 45 and 49%, respectively (P = 0.05). Both concomitant chemoradiotherapy regimens were easily given in the outpatient clinic. The regimen based on paclitaxel was significantly more tolerable and effective; however, the difference was not enormous.
Evaluation of the feasibility and efficacy of neoadjuvant concurrent chemoradiotherapy (CRT) with... more Evaluation of the feasibility and efficacy of neoadjuvant concurrent chemoradiotherapy (CRT) with capecitabine and oxaliplatin in patients with locally advanced esophageal cancer. Forty-two patients were eligible for the study. The chemotherapy during CRT consisted of two cycles of intravenous oxaliplatin of 120 mg/ m 2 on day 1 and oral capecitabine 825 mg/m 2 twice daily on days 1-14 at 3-week intervals. The radiotherapy (1.8 Gy/fraction/day to a total dose of 45 Gy) was delivered to the primary tumor site and regional lymph node. All patients completed the planned treatment. Overall clinical response rate was 54.8% with complete response in 16.7% while pathological response rate was 38%. Anemia was the commonest hematologic toxicity (52.3%) with grade 3 in 4.7%, and esophagitis was the commonest non-hematologic toxicity 59.5% with grade 3 and 4 in 9.5%. No treatment-related death was observed. After a median follow-up duration of 19 months, the 2-year survival rate was 42%, median survival time was 20 months (95%CI: 13.802-26.198), while 2-year progression-free survival (PFS) rate was 32.5% with median PFS time of 15 months (95%CI: 10.042-19.958). Neoadjuvant concurrent CRT with capecitabine and oxaliplatin was found to be well tolerated and effective in patients with locally advanced esophegeal cancer; however, these results should be further evaluated in a phase III study.
Aim: This study was conducted to assess the safety and efficacy of postoperative hypofractionated... more Aim: This study was conducted to assess the safety and efficacy of postoperative hypofractionated radiotherapy (HRT) using simultaneous integrated boost (SIB) technique for glioblastoma (GBM) compared to conventional radiotherapy (CRT). Study Design: This was a prospective study with historical control arm. Place and Duration of the Study: Department of Clinical Oncology and Nuclear Medicine, Mansoura University Hospital, Mansoura, Egypt, between May 2017 and June 2019. Methods: The intervention (HRT) group included 30 patients who received 3D conformal HRT with SIB using field in field (FIF) technique to deliver a differential radiation dose to different targets. Planning target volume 60 (PTV60) includes the gross target volume (GTV) plus a 5-mm margin, and PTV45 includes the GTV plus a 15-mm margin. PTV60 will receive 60 Gy in 20 fractions, and PTV45 will receive 45 Gy in the same 20 fractions (one fraction daily and 5 days per week).The CRT group included 30 patients who receive...
Background: Small cell lung cancer (SCLC) is a high grade neuroendocrine tumor, and has aggressiv... more Background: Small cell lung cancer (SCLC) is a high grade neuroendocrine tumor, and has aggressive nature, so the majority of cases are presented with extensive disease. SCLC was staged into 2 categories: limited-stage disease (LS-SCLC) and extensive disease (ES-SCLC). Despite SCLC is sensitive to radiotherapy and chemotherapy, SCLC has high tendency for rapid dissemination to regional and distant sites. Median survival time ranged from 2-4 months in patients with untreated SCLC. Multiagent chemotherapy was the primary treatment for SCLC. Aim of the work: This retrospective study was conducted to evaluate and analyze clinical features, treatment outcome, survival and prognostic factors affecting survival in patients with SCLC presented to Clinical Oncology and Nuclear Medicine department, Chest department and Medical oncology unit in Mansoura Oncology Centre during the period from 2000-2015. Methods: Data of patients were collected from their files. The information obtained included demographic features, treatment received; its toxicity and outcome, survival and its prognostic factors. Demographic data were: age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), smoking status, stage of disease. Data also included disease presentation and metastatic sites. Several factors affecting survival were analysed as age, sex, stage, PS, smoking status and LDH. Results: Sixty-three patients were enrolled in this study. Median age was 56.2 ± 6. Strong male predominance (92.1%) was observed; 84.1% of them were smoker. Thirty six patients (57.2%) were of ECOG-PS of 0-1. ES-SCLC was reported in 65% of cases and LDH was high (>1.5 xN) in 47.6%. The most common symptom was chest pain (38.1%) followed by cough (31.8%), weight loss (30%). Fifteen patients had single metastatic site (23.8%
Medical oncology (Northwood, London, England), 2012
Due to socioeconomic issues, locally advanced breast cancer (LABC) is still a common presentation... more Due to socioeconomic issues, locally advanced breast cancer (LABC) is still a common presentation of breast cancer in the third world. It was found that LABC patients showing a clinical response after two to four cycles of neoadjuvant chemotherapy have a higher probability of obtaining a pathological complete response at surgery than patients without an early response. In the present work, the short-term effects and toxicity of the neoadjuvant second-line vinorelbine and gemcitabine combination were evaluated in the treatment of LABC who did not show early response to anthracyclines and taxanes-containing regimen. The use of vinorelbine and gemcitabine was based on their use in metastatic breast cancer cases who had been treated before with anthracyclines and taxanes. This was a prospective phase II study accomplished at the Clinical Oncology and Nuclear Medicine Department of Mansoura University, Egypt. Seventy LABC patients not suitable for breast conservative surgery who failed t...
Triple-negative breast cancer (TNBC) is diagnosed more frequently in younger and premenopausal wo... more Triple-negative breast cancer (TNBC) is diagnosed more frequently in younger and premenopausal women and is highly prevalent in African American women. TNBC is a term derived from tumors that are characterized by the absence of ER, PgR, and HER2. So patients with TNBC do not benefit from hormonal or trastuzumab-based therapies. TNBCs are biologically aggressive, although some reports suggest that they respond to chemotherapy better than other types of breast cancer, prognosis remains poor. This is due to: shortened disease-free interval in the adjuvant and neoadjuvant setting and a more aggressive course in the metastatic setting.
American Journal of Cancer Therapy and Pharmacology, Feb 21, 2014
Several lines of evidence suggest that it is time to re-examine the approach to the patient diagn... more Several lines of evidence suggest that it is time to re-examine the approach to the patient diagnosed with distant metastases at the initial breast cancer presentation.
Clinical Oncology and Cancer Research, Sep 1, 2011
Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas ha... more Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas has been reported with gemcitabine and/or docetaxel. METHODS Forty patients with advanced soft tissue sarcomas refractory to first-line chemotherapy treatment were enrolled. They received combination of gemcitabine at dose of 900 mg/m 2 on days 1 and 8 and docetaxel at dose of 100 mg/m 2 on day 8, and had this regimen repeated every 3 weeks. If the patients had received the pelvic irradiation in advance, gemcitabine dose was reduced to 675 mg/m 2 on days 1 and 8 and docetaxel to 75 mg/m 2 on day 8, and had it repeated every 3 weeks.
The Chinese German Journal of Clinical Oncology, Aug 1, 2011
Abstract Objective Despite resection with curative intent, a majority of patients with gastric ca... more Abstract Objective Despite resection with curative intent, a majority of patients with gastric cancer will develop disease recurrence. Postoperative adjuvant chemo-radiotherapy increase the curability of surgery, prevent local recurrence and improve survival. Methods ...
Medical oncology (Northwood, London, England), 2012
A phase II trial of irinotecan and cisplatin (IP) as induction chemotherapy followed by conventio... more A phase II trial of irinotecan and cisplatin (IP) as induction chemotherapy followed by conventional thoracic irradiation concurrent with low-dose weekly cisplatin for limited-disease small-cell lung cancer (LDS-SCLC). Between February 2005 and December 2008, 34 chemotherapy-naïve patients with LD-SCLC were enrolled. Treatment consisted of two 21-day cycles of cisplatin 40 mg/m(2) and irinotecan 80 mg/m(2) intravenously (IV) on days 1 and 8 followed by conventional thoracic irradiation at a dose of 54 Gy concurrent with cisplatin at dose of 20 mg/m(2) weekly then prophylactic cranial irradiation at dose of 30 Gy in 10 fractions for those achieved complete or partial response. Only 33 patients received the treatment protocol, and they were assessed for response and toxicity. After induction chemotherapy, overall response rate was (72.73%). After median follow-up of 27 months, the median survival was 25 months (95% CI, 21.249-28.751) with 1 and 2-year overall survival rates of 83 and ...
The objective of this study was to evaluate the results of combined chemoradiotherapy using 5-flu... more The objective of this study was to evaluate the results of combined chemoradiotherapy using 5-fluorouracil and cisplatin with radiation in treatment of anal squamous cell carcinoma in terms of local control, survival, and toxicity. This study included 32 patients with histologically confirmed locally advanced anal squamous cell carcinoma (T1-4 with any N). They received chemotherapy consisted of 5-fluorouracil 1000 mg/m(2)/day on the first 5 and last 5 days of RT, cisplatin 75 mg/m(2) on days 2 and 30. External beam RT consisted of 45Gy/f/25 sessions/5 sessions per week. A boost of 9Gy/5 sessions was given to those who developed complete or partial response. Median age was 55 years with female to male ratio 2.2:1. Fifty-six percent of them had ECOGPS of 1; moderately differentiated pathology was the most common one (53 %). Thirteen patients (40.6 %) presented with N0 and 56 % presented with T2. None of the patients died of acute complications and none developed grade 4 toxicity. Non-hematological complications were more common than hematological ones. Dermatitis was the most common toxicity (59.3 %) than diarrhea and neurologic one (40.7 %). Anemia was the most frequent hematological adverse event (37.5 %). Complete response was reported in 81.2 %. After median follow-up of 25 months, local recurrence was observed in five patients (15.6 %) as the following: three in the anal canal and two in the inguinal lymph nodes. Three patients (9.4 %) developed distant metastasis (two in the liver and one in the lung), while one patient (3 %) had both local and distant metastases. Three-year overall survival rate (OS) was 81.3 %, while 3-year progression-free survival (PFS) rate was 72 %, and colostomy-free survival was 90 %. Concomitant chemoradiotherapy of 5-fluorouracil and cisplatin with radiotherapy is a highly effective and well-tolerated treatment of anal cancer. But further studies with larger number of patients are needed to support the indication to treat anal cancer using this regimen.
The Chinese-German Journal of Clinical Oncology, 2011
Abstract Objective Despite resection with curative intent, a majority of patients with gastric ca... more Abstract Objective Despite resection with curative intent, a majority of patients with gastric cancer will develop disease recurrence. Postoperative adjuvant chemo-radiotherapy increase the curability of surgery, prevent local recurrence and improve survival. Methods ...
Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas ha... more Promising anti-tumor activity in patients with metastatic or unresectable soft tissue sarcomas has been reported with gemcitabine and/or docetaxel. METHODS Forty patients with advanced soft tissue sarcomas refractory to first-line chemotherapy treatment were enrolled. They received combination of gemcitabine at dose of 900 mg/m 2 on days 1 and 8 and docetaxel at dose of 100 mg/m 2 on day 8, and had this regimen repeated every 3 weeks. If the patients had received the pelvic irradiation in advance, gemcitabine dose was reduced to 675 mg/m 2 on days 1 and 8 and docetaxel to 75 mg/m 2 on day 8, and had it repeated every 3 weeks.
Despite median survival of less than 6 months, there is a significant proportion of advanced panc... more Despite median survival of less than 6 months, there is a significant proportion of advanced pancreatic cancer patients who progress on gemcitabine that remains fit, and these patients are candidates for second-line treatment. The objective of this study is to evaluate the efficacy and safety of oxaliplatin plus 5-fluorouracil and folinic acid in patients with gemcitabine-pretreated advanced pancreatic cancer. Thirty patients with advanced pancreatic cancer who were pretreated with gemcitabine received oxaliplatin (85 mg/m(2)) on days 1 and 15 followed by leucovorin (20 mg/m(2)) and 5-fluorouracil (500 mg/m(2)) on days 1, 8, and 15. The cycle was repeated every 3 weeks. The majority of patients (80 %) had locally advanced disease. Median age was 63 years, and 60 % were males. The liver was the most common site of metastasis. Partial response was observed in 2 patients (6.7 %) and stable disease in 6 patients (20 %), while 12 patients progressed (40 %). Improved performance status was reported in 10 patients (33.3 %). The median duration of response was 13 weeks, and median overall survival was 22 weeks. There was no grade 4 toxicity apart from grade 4 neutropenia in 6.6 % of patients. Neutropenia (46.5 %) and neuropathy (43.2 %) were the most common toxicities, while hand-foot syndrome was the least frequent one (20 %). There were no treatment-related deaths. The 6-month survival rate was 30 %. This regimen is feasible and active with an acceptable toxicity; however, further investigation in phase III trial is needed.
Objective To evaluate toxicity and efficacy of addition of weekly irinotecan to a regimen of chem... more Objective To evaluate toxicity and efficacy of addition of weekly irinotecan to a regimen of chemoradiotherapy of 5fluorouracil with concurrent pelvic radiation in patients with locally advanced rectal cancer. Patients and methods Between October 2006 and December 2009, 36 patients with non-metastatic rectal adenocarcinoma were treated with chemoradiotherapy of irinotecan (50 mg/m 2 weekly), 5-fluorouracil (250 mg/m 2 for 5 days/week) and pelvic radiation (45 Gy/1.8 Gy/fraction for 5 days/week) by 3D conformal radiotherapy. Results All patients completed the planned treatment. After the chemoradiotherapy, overall clinical response rate was 55.5% and pathological complete was 16.7%. Neutropenia was the most common hematologic toxicity (58.3%) with grade III in 5.5% while among non hematologic toxicity, diarrhea was the most common reported one (63.9%) with grade III in 13.9% followed by nausea and vomiting (47.2%). After a median follow-up of 23 months, progression-free and overall survival estimates at 2 years were 72% and 91.7%, respectively. Distant relapses were recoded in 16.7%, the main distant failure sites were lung and liver, and local relapse was found in 5.6%.
The objective of this study was to compare concomitant chemoradiotherapy based on weekly low-dose... more The objective of this study was to compare concomitant chemoradiotherapy based on weekly low-dose gemcitabine versus weekly low-dose paclitaxel in locally advanced head and neck squamous cell carcinoma. Previously, untreated patients with locally advanced squamous cell carcinoma of the head and neck were randomly assigned to one of the two concomitant chemoradiation regimens: (1) weekly gemcitabine at a dose of 100 mg/m(2) over 30 min 1-2 h before radiotherapy and (2) weekly paclitaxal at a dose of 20 mg/m(2) over 60 min 4-6 h before radiotherapy. The planned radiotherapy dose was 65 Gy over 6.5 weeks in 32 settings. Two hundred and sixteen patients were randomly divided into 2 groups: group A (110 patients) and group B (106 patients) who received concomitant weekly low-dose gemcitabine and low-dose paclitaxal, respectively, with the radiotherapy protocol. The hematological toxicity was generally mild. On the contrary, non-hematologic toxicities were severe. Grade III mucositis occurred in 36% in group A and in 24% in group B (P = 0.04). Moreover, grade III dermatitis were encountered in 24% in group A and 13% in group B (P = 0.049). Thirty-two (29%) of group A and 18(17%) of group B patients required enteral or parenteral feeding (P = 0.01). Sixteen (15%) of group A and 6 (6%) of group B required enteral or parenteral feeding that lasted for 6 months (P = 0.03). Regarding the late effect on swallowing, 8% of patients in group A and 2% of patients in group B required enteral or parenteral feeding for more than 6 months (P = 0.035). Response rates were 78 and 89% in groups A and B, respectively (P = 0.038). The 2-year progression-free survival figures were 54 and 64% of groups A and B, respectively; however, the 2-year overall survival figures were 56 and 67%, respectively. On the other hand, the 3-year progression-free survival figures were 39 and 48% for groups A and B, respectively, while the 3-year overall survival figures were 45 and 49%, respectively (P = 0.05). Both concomitant chemoradiotherapy regimens were easily given in the outpatient clinic. The regimen based on paclitaxel was significantly more tolerable and effective; however, the difference was not enormous.
Evaluation of the feasibility and efficacy of neoadjuvant concurrent chemoradiotherapy (CRT) with... more Evaluation of the feasibility and efficacy of neoadjuvant concurrent chemoradiotherapy (CRT) with capecitabine and oxaliplatin in patients with locally advanced esophageal cancer. Forty-two patients were eligible for the study. The chemotherapy during CRT consisted of two cycles of intravenous oxaliplatin of 120 mg/ m 2 on day 1 and oral capecitabine 825 mg/m 2 twice daily on days 1-14 at 3-week intervals. The radiotherapy (1.8 Gy/fraction/day to a total dose of 45 Gy) was delivered to the primary tumor site and regional lymph node. All patients completed the planned treatment. Overall clinical response rate was 54.8% with complete response in 16.7% while pathological response rate was 38%. Anemia was the commonest hematologic toxicity (52.3%) with grade 3 in 4.7%, and esophagitis was the commonest non-hematologic toxicity 59.5% with grade 3 and 4 in 9.5%. No treatment-related death was observed. After a median follow-up duration of 19 months, the 2-year survival rate was 42%, median survival time was 20 months (95%CI: 13.802-26.198), while 2-year progression-free survival (PFS) rate was 32.5% with median PFS time of 15 months (95%CI: 10.042-19.958). Neoadjuvant concurrent CRT with capecitabine and oxaliplatin was found to be well tolerated and effective in patients with locally advanced esophegeal cancer; however, these results should be further evaluated in a phase III study.
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