Cancer Chemother Pharmacol (1991) 29: 83- 84
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9 Springer-Verlag 1991
Etoposide, folinic acid, and 5-fluorouracil in carboplatin-pretreated patients with advanced gastric cancer Hansjochen Wilkel, Peter Preusser 2, Michael Stahl I, Andreas Harstrick 3, Hans-Joachim Meyer 1, W o l f A c h t e r r a t h 3, H a n s - J o a c h i m S c h m o l P , a n d S i e g f r i e d Seeber~ I Department of Internal Medicine (Cancer Research), West German Cancer Center, Essen University Medical School, 4300 Essen, Federal Republic of Germany 2 Department of Surgery, University Mtinstor Medical School, 4400 Mtinster, Federal Republic of Germany 3 Departments of Hematotogy/Oncology and Surgery, Hannover University Medical School, 3000 Hannover, Federal Republic of Germany Received 1 July 1991/Accepted 12 August 1991
S u m m a r y . A group o f 20 patients with gastric cancer, refractory to or with no c h a n g e after two or three cycles o f c a r b o p l a t i n were treated with etoposide/folinic acid/5-fluorouracil (ELF). A n o b j e c t i v e r e m i s s i o n rate o f 45 % (9/20), a m e d i a n remission duration o f 8 months and a m e d i a n survival time o f 11 months were achieved. Toxicities w e r e m i l d to m o d e r a t e only. T h e s e results are c o m p a r a b l e to those being a c h i e v e d with E L F in p r e v i o u s l y untreated gastric cancer patients and c o n f i r m its efficacy and g o o d tolerability.
Introduction Carboplatin, a s e c o n d - g e n e r a t i o n p l a i n a n a l o g u e with a m o l e c u l a r m o d e o f action c o m p a r a b l e to cisplatin has been investigated in a d v a n c e d gastric cancer b y our group using a fractionated day-1,3,5 schedule . Patients with early t u m o u r p r o g r e s s i o n or no sign o f t u m o u r regression after 2(3) cycles o f c a r b o p l a t i n were taken off study and rec e i v e d etoposide/folinic acid/5-fluorouracil ( E L F ) as seco n d - l i n e treatment. E L F was chosen b e c a u s e o f its activity in untreated gastric cancer patients [5, 6] and lack o f crossresistance b e t w e e n carboplatin, etoposide, and 5-fluorouracil in vitro and in vivo.
chest CT if indicated. Liver and renal function were monitored prior to each cycle and blood counts weekly during treatment. Tumour response and side-effects were assessed prior to each chemotherapy cycle, 4 weeks after the last one and then every 3 months. The evaluation of tumour response and documentation of side-effects were done according to WHO criteria . Median remission duration and median survival time were calculated using the Kaplan-Meier method. Out of 24 patients treated with carboplatin, 20 have been entered into this trial. All patients had at least one measurable lesion and histologically confirmed gastric cancer. The median age was 63 years (49-70), the median WHO performance status 1 (0-2). Two patients had only locally advanced disease and 18 patients had distant metastases (liver with or without other sites except for peritoneal carcinosis 13, lymph nodes 2, peritoneal carcinosis + other sites 3). According to the Lauren classification 13 patients had intestinal-type and 7 diffuse-type gastric cancer. Twelve patients had progressive disease during carboplatin treatment and 8 patients had no change when entering the trial. Chemotherapy consismd of folinic acid 300 mg/m2 10 rain i. v. foitowed by etoposide 120 mg/m 2 50 n-tin i.v. followed by 5-fluorouracil 500 mg/m2 10 min i.v. on days 1-3, every 22 days. Patients without tumour progression during ELF treatment received up to 6 cycles depending on side-effects.
Results All 20 patients w e r e e v a l u a b l e for response, toxicity and survival. A total o f 91 cycles [median 5 ( 1 - 6 ) ] were administered; 9 (45%) partial remissions were achieved, 6 (30%) patients had no change and 5 (25%) had progressive disease. B o t h patients with l o c a l l y a d v a n c e d disease
Materials and methods Eligibility criteria included histologically confirmed inesectable or metastasized adenocarcinoma of the stomach, measurable disease, performance status