Indian journal of cancer · 2006
Phase II study of cisplatin, etoposide and paclitaxel in locally advanced or metastatic adenocarcinoma of gastric/gastroesophageal junction.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Sharma Atul, Raina V, Lokeshwar N, Deo S V S, Shukla N K, Mohanti B K
Аннотация
BACKGROUND: Unresectable and metastatic gastric cancers carry a poor and dismal prognosis. Several phase II studies have identified effective anticancer drugs.
AIMS: To evaluate safety and efficacy of low-dose cisplatin, etoposide and paclitaxel (CEP) based combination chemotherapy in locally advanced or metastatic adenocarcinoma of gastric/gastroesophageal junction.
SETTING AND DESIGN: Prospective single-arm phase II study.
MATERIALS AND METHODS: Thirty-three patients were enrolled onto this study, out of which, all but one received cisplatin 15 mg/m 2, etoposide 40 mg/m 2 and paclitaxel 50 mg/m 2, given on day 1 and 4 every week for three weeks in a 28-day cycle. Survival analysis was done using SPSS program.
RESULTS: Median age of group was 56 years. Twenty-five were males. Twenty-nine had metastatic/inoperable disease and four patients had recurrent disease. Liver was the commonest metastatic site seen in 15 patients. With a median of 2 cycles per patient, a total of 76 cycles was administered. Grade III or IV toxicity were seen in 11 (35%) patients; diarrhea, 5 patients; vomiting, 3 patients; and neutropenia, 7 patients, 5 of whom also had fever). One patient died of neutropenic fever. Best responses, seen in 32 evaluable patients, were 2 CR (6.1%), 21 PR (63%) and 3 SD (9.2%). Four patients were considered operable after chemotherapy. With median follow-up of 11 months in surviving patients, median OS was 10 months and PFS was 8 months. Median OS was 13 months in responders versus 8 months in nonresponders (P =0.04). Seven patients survived> 12 months.
CONCLUSION: Combination of low-dose CEP shows good clinical response and an acceptable toxicity profile in advanced or metastatic adenocarcinoma of gastric/gastroesophageal cancers. Whether addition of 5 FU or capecitabine adds to the benefit should be explored. This may be tested with other standard/conventional protocols in a randomized fashion.
AIMS: To evaluate safety and efficacy of low-dose cisplatin, etoposide and paclitaxel (CEP) based combination chemotherapy in locally advanced or metastatic adenocarcinoma of gastric/gastroesophageal junction.
SETTING AND DESIGN: Prospective single-arm phase II study.
MATERIALS AND METHODS: Thirty-three patients were enrolled onto this study, out of which, all but one received cisplatin 15 mg/m 2, etoposide 40 mg/m 2 and paclitaxel 50 mg/m 2, given on day 1 and 4 every week for three weeks in a 28-day cycle. Survival analysis was done using SPSS program.
RESULTS: Median age of group was 56 years. Twenty-five were males. Twenty-nine had metastatic/inoperable disease and four patients had recurrent disease. Liver was the commonest metastatic site seen in 15 patients. With a median of 2 cycles per patient, a total of 76 cycles was administered. Grade III or IV toxicity were seen in 11 (35%) patients; diarrhea, 5 patients; vomiting, 3 patients; and neutropenia, 7 patients, 5 of whom also had fever). One patient died of neutropenic fever. Best responses, seen in 32 evaluable patients, were 2 CR (6.1%), 21 PR (63%) and 3 SD (9.2%). Four patients were considered operable after chemotherapy. With median follow-up of 11 months in surviving patients, median OS was 10 months and PFS was 8 months. Median OS was 13 months in responders versus 8 months in nonresponders (P =0.04). Seven patients survived> 12 months.
CONCLUSION: Combination of low-dose CEP shows good clinical response and an acceptable toxicity profile in advanced or metastatic adenocarcinoma of gastric/gastroesophageal cancers. Whether addition of 5 FU or capecitabine adds to the benefit should be explored. This may be tested with other standard/conventional protocols in a randomized fashion.