Objectives: Our objectives were to confirm the activity of O-MAX chemotherapy in adenocarcinoma of the stomach and esophagus, particularly the high rate of complete remission (CR) and the relation of subclinical hemolysis to CR. Patients and Methods: Twenty-five patients with metastatic esophagogastric adenocarcinoma were treated with O-MAX. Two developed cancer-related hemolytic-uremic syndrome (C-HUS); both achieved CR. Subsequent patients were monitored for serum haptoglobin for subclinical hemolysis. Results: Median survival was 16.5 months. The objective response rate was 90%, with 38% CR. Three patients achieving CR relapsed in the central nervous system and died (2 without systemic disease). Four patients have remained alive, off therapy, the longest for 20 years. Two patients developed clinical C-HUS and 5 of 8 monitored patients developed subclinical hemolysis based on abnormal serum haptoglobin. Four of the patients with subclinical hemolysis achieved CR. Of the 7 patients developing clinical C-HUS or subclinical hemolysis, 6 (86%) achieved CR. Conclusions: O-MAX appears highly active in esophagogastric adenocarcinoma. A few long-term survivors of metastatic disease are being seen. CR and long-term survival appear to correlate with the development of hemolysis. Although highly promising, these results should be considered only as hypothesis-generating and require confirmation in a prospective trial.

Parkin DM, Läärä E, Muir CS: Estimates of the worldwide frequency of sixteen major cancers in 1980. Int J Cancer 1988;41:184-197.
Ferlay J, Shin H-R, Bray F, et al: Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-2912.
Siegel R, Jemal A, Naishadham MA: Cancer statistics, 2013. CA Cancer J Clin 2013;63:11-30.
Macdonald JS, Schein PS, Woolley PV, et al: 5-Fluorouracil, doxorubicin and mitomycin (FAM) combination chemotherapy for advanced gastric cancer. Ann Intern Med 1980;93:533-536.
Cantrell JE, Phillips TM, Schein PS: Carcinoma-associated hemolytic-uremic syndrome: a complication of mitomycin C chemotherapy. J Clin Oncol 1985;3:723-734.
Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216.
Kaplan EI, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457.
Schemper M, Smith TL: A note on quantifying follow-up in studies of failure time. Control Clin Trials 1996;17:343-345.
Preusser P, Wilke H, Achterrath W, et al: Phase II study of the combination of etoposide, doxorubicin and cisplatin in advanced measurable gastric cancer. J Clin Oncol 1989;7:1310-1317.
Wils JA, Klein HO, Wagener PJT, et al: Sequential high-dose methotrexate and fluorouracil combined with doxorubicin - a step ahead in the treatment of advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group. J Clin Oncol 1991;9:827-831.
Kelsen D, Atiq OT, Saltz L, et al: FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol 1992;10:541-548.
Lokich JJ, Ahlgren JD, Gullo JJ, Philips JA, Fryer JG: A prospective randomized comparison of continuous infusion 5-fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: a Mid-Atlantic Oncology Program study. J Clin Oncol 1989;7:425-432.
Schüller J, Cassidy J, Dumont E, et al: Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000;45:291-297.
Findlay M, Cunningham D, Norman A, et al: A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF). Ann Oncol 1994;5:609-616.
Webb A, Cunningham D, Scarffe JH, et al: Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 1997;15:261-267.
Ross P, Nicolson M, Cunningham D, et al: Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI-5FU) with epirubicin, cisplatin, and PVI-5FU in advanced esophagogastric cancer. J Clin Oncol 2002;20:1996-2004.
Cunningham D, Starling N, Rao S, et al: Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 2008;358:36-46.
Cunningham D, Allum WH, Stenning SP, et al: Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 2006;355:11-20.
Van Cutsem E, Moiseyenko VM, Tjulandin S, et al: Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 2006;24:4991-4997.
Louvet C, André T, Tigaud JM, et al: Phase II study of oxaliplatin, fluorouracil, and folinic acid in locally advanced or metastatic gastric cancer patients. J Clin Oncol 2002;20:4543-4548.
Enzinger PC, Burtness B, Hollis D, et al: CALGB 80403/ECOG 1206: a randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer. J Clin Oncol 2010;28:4006.
Koizumi W, Narahara H, Hara T, et al: S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 2008;9:215-921.
Ohtsu A, Shah MA, Van Cutsem E, et al: Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 2011;29:3958-3976.
Bang Y-J, Van Cutsem E, Feyereislova A, et al: Transtuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomized controlled trial. Lancet 2010;376:687-696.
Watson S, Validire P, Cervera P, et al: Combined HER2 analysis of biopsies and surgical specimens to optimize detection of transtuzimab-eligible patients in eso-gastric adenocarcinoma: a GERCOR study. Ann Oncol 2013;24:3035-3039.
Park JO, Chung HC, Cho JY, et al: Retrospective comparison of infusional 5-fluorouracil, doxorubicin, and mitomycin-C (modified FAM) combination chemotherapy versus palliative therapy in treatment of advanced gastric cancer. Am J Clin Oncol 1997;20:484-489.
Raschko JW, Johnson EA, Ueno W, Woolley PV, Treat J: Continuous infusion 5-fluorouracil with bolus adriamycin and mitomycin and low-dose cisplatin (FAMP) in the treatment of metastatic gastric carcinoma: an evaluation of efficacy and toxicity. Cancer Invest 1991;9:49-51.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.