Multifractionated cisplatin, etoposide, and paclitaxel, (CEP) in unresectable gastric/gastro esophageal (GE) cancer: Phase II study

Abstract

4203 Background: Gastric cancer is leading cause of cancer related mortality. Unlike, Japan where screening helps in detection of early cancers, two third patients elsewhere present in advanced stage where cure is unlikely. These patients are given palliative treatment and median survival ranges from 5–7 months. Over last few years lot of advances have been made in surgical and adjuvant treatment. Still, prognosis and treatment of unresectable disease remains dismal. The most commonly used drugs are 5 fluorauracil, mitomycin, doxorubicin, etoposide, cisplatin, and taxanes either signally or in combinations. This trial was designed to evaluate safety and efficacy of low dose, multifractionated CEP in unresectable gastric/ GE cancers. Patients and Methods: Thirty-three inoperable patients were enrolled onto this study after obtaining informed consent to receive cisplatin 15mg/m2, etoposide 40 mg/m2, and paclitaxel 50mg/m2 all day 1 and 4 every week for three week in a 4 weekly cycle. Results: Median age was 56 years (range 32 to 70 years), 25 were males. Twenty nine inoperable disease and 4 had recurrent disease. Liver and ascites were commonest metastatic sites seen in 15 and 11 patients. Twenty-four patients had symptom control after 1 cycle. Total 76 cycles were administered (median 2). Grade III or IV toxicity seen in 11 (36%) patients; diarrhea (5), neutropenia (7 patients 5 with fever). One patient died of neutropenic fever. Best responses seen in 29 evaluable patients were; 2 CR (6.4%), 17 PR (55%), 3 SD (9.6%), and 4 PD (13%). Four patients were considered operable after chemotherapy. Median OS and PFS were 10 and 7 months respectively. Median OS was 13 months in responders versus 8 months in non responders (p=0.04). Seven (22%) survived 12 months or more. Conclusion: CEP has shown good clinical response and an acceptable toxicity profile in advanced cancers. Better responses may help in prolonging survival. This may be tested with other protocols in a randomized fashion. No significant financial relationships to disclose.