PURPOSE: We conducted a multicenter phase II study to assess the toxicity and efficacy of a combination of mitomycin C (MMC) and capecitabine in pretreated patients with metastatic or locally advanced gastric cancer. METHODS: Thirty-nine patients (77 % male) between 33 and 78 years (median 66) with pretreated locally advanced or metastatic esophagogastric adenocarcinoma and eastern cooperative oncology group performance status of ≤2, measurable lesions, and adequate organ functions were recruited into the study. Eight patients (21 %) had received more than one prior chemotherapy regimen. Treatment consisted of three-weekly MMC 10 mg/m(2) day 1 and capecitabine 2,000 mg/m(2) (day 1-14; repeated day 22). RESULTS: A median of three cycles of therapy was administered. Grade 3 toxicity occurred in 20 patients (54 %). Main grade 3 adverse events were thrombocytopenia (11 %, n = 4), fatigue (8 %, n = 3), and neuropathy (8 %, n = 3). Two events of grade 4 toxicity were reported (5 %) (dyspnea and elevation of alkaline phosphatase due to bone metastases). Partial remission was noticed in 10.3 % (n = 4), stable disease in 33.3 % (n = 13) adding to a tumor control rate of 43.6 %. The median progression-free and overall survival were 2.8 and 5.6 months, respectively. CONCLUSION: The combination of MMC and capecitabine exhibited a favorable tolerability profile in pretreated patients with gastric cancer. The disease control rate compares adequately with that of other phase II and phase III trials for second-line therapy in gastric cancer. This regimen may be considered as an alternative second-line treatment, especially for patients not suitable for or pretreated with taxanes and/or irinotecan.
PURPOSE: We conducted a multicenter phase II study to assess the toxicity and efficacy of a combination of mitomycin C (MMC) and capecitabine in pretreated patients with metastatic or locally advanced gastric cancer. METHODS: Thirty-nine patients (77 % male) between 33 and 78 years (median 66) with pretreated locally advanced or metastatic esophagogastric adenocarcinoma and eastern cooperative oncology group performance status of ≤2, measurable lesions, and adequate organ functions were recruited into the study. Eight patients (21 %) had received more than one prior chemotherapy regimen. Treatment consisted of three-weekly MMC 10 mg/m(2) day 1 and capecitabine 2,000 mg/m(2) (day 1-14; repeated day 22). RESULTS: A median of three cycles of therapy was administered. Grade 3 toxicity occurred in 20 patients (54 %). Main grade 3 adverse events were thrombocytopenia (11 %, n = 4), fatigue (8 %, n = 3), and neuropathy (8 %, n = 3). Two events of grade 4 toxicity were reported (5 %) (dyspnea and elevation of alkaline phosphatase due to bone metastases). Partial remission was noticed in 10.3 % (n = 4), stable disease in 33.3 % (n = 13) adding to a tumor control rate of 43.6 %. The median progression-free and overall survival were 2.8 and 5.6 months, respectively. CONCLUSION: The combination of MMC and capecitabine exhibited a favorable tolerability profile in pretreated patients with gastric cancer. The disease control rate compares adequately with that of other phase II and phase III trials for second-line therapy in gastric cancer. This regimen may be considered as an alternative second-line treatment, especially for patients not suitable for or pretreated with taxanes and/or irinotecan.
Authors: Jaffer A Ajani; Miguel B Fodor; Sergei A Tjulandin; Vladimir M Moiseyenko; Yee Chao; Sebastiao Cabral Filho; Alejandro Majlis; Sylvie Assadourian; Eric Van Cutsem Journal: J Clin Oncol Date: 2005-08-20 Impact factor: 44.544
Authors: Peter C Thuss-Patience; Albrecht Kretzschmar; Dmitry Bichev; Tillman Deist; Axel Hinke; Kirstin Breithaupt; Yasemin Dogan; Bernhard Gebauer; Guido Schumacher; Peter Reichardt Journal: Eur J Cancer Date: 2011-10 Impact factor: 9.162
Authors: Jung Hun Kang; Soon Il Lee; Do Hyoung Lim; Keon-Woo Park; Sung Yong Oh; Hyuk-Chan Kwon; In Gyu Hwang; Sang-Cheol Lee; Eunmi Nam; Dong Bok Shin; Jeeyun Lee; Joon Oh Park; Young Suk Park; Ho Yeong Lim; Won Ki Kang; Se Hoon Park Journal: J Clin Oncol Date: 2012-03-12 Impact factor: 44.544
Authors: Eric Van Cutsem; Vladimir M Moiseyenko; Sergei Tjulandin; Alejandro Majlis; Manuel Constenla; Corrado Boni; Adriano Rodrigues; Miguel Fodor; Yee Chao; Edouard Voznyi; Marie-Laure Risse; Jaffer A Ajani Journal: J Clin Oncol Date: 2006-11-01 Impact factor: 44.544
Authors: Salah-Eddin Al-Batran; Claudia Pauligk; Nils Homann; Jörg T Hartmann; Markus Moehler; Stephan Probst; Volker Rethwisch; Jan Stoehlmacher-Williams; Nicole Prasnikar; Stephan Hollerbach; Carsten Bokemeyer; Rolf Mahlberg; Ralf D Hofheinz; Kim Luley; Frank Kullmann; Elke Jäger Journal: Eur J Cancer Date: 2012-10-11 Impact factor: 9.162
Authors: David Cunningham; Naureen Starling; Sheela Rao; Timothy Iveson; Marianne Nicolson; Fareeda Coxon; Gary Middleton; Francis Daniel; Jacqueline Oates; Andrew Richard Norman Journal: N Engl J Med Date: 2008-01-03 Impact factor: 91.245