Pegylated liposomal doxorubicin and mitomycin C in combination with infusional 5-fluorouracil and sodium folinic acid in the treatment of advanced gastric cancer

• Verfasst von: Gnad-Vogt, Ulrike [VerfasserIn]
• Verfasst von: Hofheinz, Ralf-Dieter [VerfasserIn]
• Verfasst von: Saußele, Susanne [VerfasserIn]
• Verfasst von: Kreil, Sebastian [VerfasserIn]
• Verfasst von: Willer, Andreas [VerfasserIn]
• Verfasst von: Willeke, Frank [VerfasserIn]
• Verfasst von: Pilz, Lothar R. [VerfasserIn]
• Verfasst von: Hehlmann, Rüdiger [VerfasserIn]
• Verfasst von: Hochhaus, Andreas [VerfasserIn]
• Titel: Pegylated liposomal doxorubicin and mitomycin C in combination with infusional 5-fluorouracil and sodium folinic acid in the treatment of advanced gastric cancer
• Titelzusatz: results of a phase II trial
• Verf.angabe: Senta Ulrike Gnad-Vogt, Ralf-Dieter Hofheinz, Susanne Saussele, Sebastian Kreil, Andreas Willer, Frank Willeke, Lothar Pilz, Rüdiger Hehlmann and Andreas Hochhaus
• E-Jahr: 2005
• Jahr: April 2005
• Umfang: 6 S.
• Fussnoten: Gesehen am 12.05.2022
• Titel Quelle: Enthalten in: Anti-cancer drugs
• Ort Quelle: Hagerstown, Md. : Lippincott Williams & Wilkins, 1990
• Jahr Quelle: 2005
• Band/Heft Quelle: 16(2005), 4, Seite 435-440
• ISSN Quelle: 1473-5741
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1801661332

Abstract

Mitomycin C (MMC) in combination with infusional 5-fluorouracil (5-FU) is a well-tolerated active combination therapy for advanced gastric cancer. Pegylated liposomal doxorubicin (Caelyx) has been combined with this regimen in a phase I study exhibiting promising activity in patients with upper gastrointestinal tumors. In the present study, we investigated activity and tolerability of this three-drug regimen in patients with gastric cancer. Patients with advanced or metastatic gastric cancer were recruited to receive weekly infusional 5-FU (2000 mg/m2) mixed with sodium folinic acid (FA; 500 mg/m2) in one pump (days 1, 8, 15, 22, 29, 36). On days 1 and 29, Caelyx (20 mg/m2) was given as a 1-h, and MMC (7 mg/m2) was applied as bolus injection on days 8 and 36. Treatment courses were repeated on day 57. Twenty-seven patients with a median age of 66 years were recruited in a single center; 56% had histologically proven peritoneal carcinomatosis and 26 patients are evaluable for toxicity. Common Toxicity Criteria of the National Cancer Institute grade 3 toxicity was recorded in 34% of the patients (anemia 12%, leukocytopenia 8%, febrile neutropenia 4%, thrombocytopenia 12%, nausea 15%, diarrhea 8% and mucositis 4%). One patient developed hemolytic-uremic syndrome. One complete (5%) and eight partial responses (42%) were observed in 19 patients evaluable for response according to WHO criteria. Seven patients had no change (37%) and three (16%) progressive disease. Six patients with peritoneal carcinomatosis not amenable to WHO response assessment had progression-free intervals between 8 and 21 months. Median survival for all patients was 14.7 months and median time to progression was 8.4 months. We conclude that this new three-drug combination regimen yields a promising overall response rate (47%) in patients with gastric cancer despite the inclusion of a majority of elderly patients at moderate or high risk of death in this trial. Its safety and good tolerability as established in the phase I trial was confirmed.