Phase II study of cisplatin, etoposide and paclitaxel in locally advanced or metastatic adenocarcinoma of gastric/gastroesophageal junction.
Indian J Cancer
; 2006 Jan-Mar; 43(1): 16-9
Article
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| IMSEAR
| ID: sea-49953
ABSTRACT
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 ANDDESIGN:
Prospective single-arm phase II study. MATERIALS ANDMETHODS:
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.
Texte intégral:
1
Indice:
IMSEAR
Sujet Principal:
Tumeurs de l'estomac
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Sujet âgé
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Femelle
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Humains
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Mâle
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Adénocarcinome
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Protocoles de polychimiothérapie antinéoplasique
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Taux de survie
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Études prospectives
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Cisplatine
Type d'étude:
Clinical_trials
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Guideline
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Observational_studies
langue:
En
Texte intégral:
Indian J Cancer
Année:
2006
Type:
Article