Phase II study of cisplatin, etoposide and paclitaxel in locally advanced or metastatic adenocarcinoma of gastric/gastroesophageal junction.
BACKGROUND
Unresectable and metastatic gastric cancers carry a poor and dismal prognosis. Several phase II studies have identified effective anticancer drugs.


OBJECTIVE
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.


METHODS
Prospective single-arm phase II study.


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.


CONCLUSIONS
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.
Sharma
Atul
A
Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India. atul1@hotmail.com
Raina
V
V
Lokeshwar
N
N
Deo
S V S
SV
Shukla
N K
NK
Mohanti
B K
BK
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004943:Esophagogastric Junction / Q000187:drug effects*; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate
D005047:Etoposide; D017239:Paclitaxel; D002945:Cisplatin