Carboplatin in combination with raltitrexed in recurrent and metastatic headand neck squamous cell carcinoma: A multicentre phase II study of the GruppoOncologico Dell'Italia Meridionale (G.O.I.M.)

Vittorio Gebbia, Ida Pucci, Maurizio Di Bisceglie, Nicola Borsellino, Vittorio Gebbia, Domenico Galetta, Domenico Galetta, Domenico Galetta, Francesco Giotta, Domenico Galetta, Giuseppe Colucci, Luigi Manzione, Gerardo Rosati

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5 Citations (Scopus)

Abstract

ackground: The combination of cisplatin (CDDP) and 5-Fluorouracil (5-FU) is a standard regimen for the treatment of recurrent and metastatic head and neck squamous cell carcinoma (HNSCC). This combination shows a relevant toxicity and new chemotherapy associations with a more favourable toxicity profile are awaited. Carboplatin (CB) is a platinum derivative with less toxicity than CDDP. Raltitrexed (R) is a potent and specific thymidylate synthase inhibitor with activity comparable to that of 5-FU in colorectal cancer; moreover, it showed activity as a single agent in HNSCC. Materials and Methods: Since 2001, a multicentre, phase II trial has been underway to evaluate the efficacy and toxicity of the CB+R combination in untreated patients with recurrent or metastatic HNSCC. Thirty-two patients were enrolled and included in an intent-to-treat analysis. Toxicity was graded according to NCI criteria. Patients had a histo/cytologically proven recurrent or metastatic HNSCC; patients with locally advanced disease not amenable to CDDP+5-FU treatment were also included. Patients had to be > 18 years old with ECOG PS of 0-2 and adequate bone marrow, renal and liver functions. CB (AUC 5) and R (3 mg/m 2) were administered intravenously every 3 weeks. The median age was 62 years (range 43-71), 29 M/3 F. The median PS was 1 (0-2). Twelve patients were staged III and 20 were metastatic (10 recurrent). The oral cavity/oropharynx were the primary site in 20 patients and the larynx in 10 patients. The median number of cycles delivered was 3, while globally 115 cycles were administered. The median time to progression was 4.2 months and median duration of survival was 9.8 months. Results: Seven patients achieved a partial response (22%), 10 patients showed a stable disease (31%), while 13 patients (48%) had progressive disease. Eight patients (25%) had a G 3-4 neutropenia, while G 3-4 anaemia was observed in 2 patients and thrombocytopenia in 1 patient. No extrahaematological G 3-4 toxicities were observed. A persistent G 2 hepatic toxicity led a patient to drop out from the study. Conclusion: In our phase II trial, CB in combination with R showed a moderate activity with safe administration on an outpatient basis
Original languageEnglish
Pages (from-to)4445-4449
Number of pages5
JournalAnticancer Research
Volume25
Publication statusPublished - 2005

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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