Epirubicin, methotrexate and bleomycin in the management of recurrent squamous cell head and neck cancer. A GSTTC randomised phase II study

Adriano Paccagnella, Giovanni L. Pappagallo, Romana Segati, Pierluigi Zorat, Giancarlo Cavaniglia, Francesco Lunghi, Vincenzo Migliorini, Alberto Frattina, Antonio Bianco, Vanna Chiarion Sileni, Savina M. Luciana Aversa, Adolfo Favaretto, Orazio Vinante, Mario V. Fiorentino

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Abstract

53 patients with squamous cell carcinoma of the head and neck recurrent after initial treatment were entered into a phase II trial of the epirubicin, methotrexate and bleomycin (EMB) combination. The primary objective of the study was to evaluate the activity of this combination. Compliance to EMB and the possible non-cross-resistance to previous cisplatin-containing chemotherapy were secondary objectives. In order to avoid patient selection bias, the study involved randomisation between EMB and a cisplatin-methotrexate-bleomycin (DMB) combination (with EMB: DMB = 2:1). 23 out of 53 (43% ± 13) EMB patients showed an objective response, lasting a median of 12 (range 4-39) weeks; interestingly, 5 out of 14 (36% ± 25) patients pretreated with cisplatin plus 5-fluorouracil responded to EMB. The treatment compliance was good and a median of three courses was delivered. No patient refused the treatment after the initial cycle. Leukopenia (47%) and oral mucositis (42%) were the main side effects. DMB produced a response rate of 33% ± 18 with a median duration of 5 (4-13) weeks. None of the patients previously treated with cisplatin plus 5-fluorouracil responded. 5 patients refused the treatment after the first cycle and a median of two cycles (0-5) was delivered. In conclusion, EMB produced results similar to cisplatin-containing regimens, with a mild to moderate toxicity and a good compliance; the possible non cross-resistance with cisplatin plus 5-fluorouracil deserves further evaluation.

Original languageEnglish
Pages (from-to)704-708
Number of pages5
JournalEuropean Journal of Cancer
Volume29
Issue number5
DOIs
Publication statusPublished - 1993

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Squamous Cell Neoplasms
Epirubicin
Bleomycin
Head and Neck Neoplasms
Methotrexate
Cisplatin
Fluorouracil
Stomatitis
indium-bleomycin
Selection Bias
Leukopenia
Therapeutics
Random Allocation
Patient Selection
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Hematology

Cite this

Epirubicin, methotrexate and bleomycin in the management of recurrent squamous cell head and neck cancer. A GSTTC randomised phase II study. / Paccagnella, Adriano; Pappagallo, Giovanni L.; Segati, Romana; Zorat, Pierluigi; Cavaniglia, Giancarlo; Lunghi, Francesco; Migliorini, Vincenzo; Frattina, Alberto; Bianco, Antonio; Chiarion Sileni, Vanna; Luciana Aversa, Savina M.; Favaretto, Adolfo; Vinante, Orazio; Fiorentino, Mario V.

In: European Journal of Cancer, Vol. 29, No. 5, 1993, p. 704-708.

Research output: Contribution to journalArticle

Paccagnella, A, Pappagallo, GL, Segati, R, Zorat, P, Cavaniglia, G, Lunghi, F, Migliorini, V, Frattina, A, Bianco, A, Chiarion Sileni, V, Luciana Aversa, SM, Favaretto, A, Vinante, O & Fiorentino, MV 1993, 'Epirubicin, methotrexate and bleomycin in the management of recurrent squamous cell head and neck cancer. A GSTTC randomised phase II study', European Journal of Cancer, vol. 29, no. 5, pp. 704-708. https://doi.org/10.1016/S0959-8049(05)80350-8
Paccagnella, Adriano ; Pappagallo, Giovanni L. ; Segati, Romana ; Zorat, Pierluigi ; Cavaniglia, Giancarlo ; Lunghi, Francesco ; Migliorini, Vincenzo ; Frattina, Alberto ; Bianco, Antonio ; Chiarion Sileni, Vanna ; Luciana Aversa, Savina M. ; Favaretto, Adolfo ; Vinante, Orazio ; Fiorentino, Mario V. / Epirubicin, methotrexate and bleomycin in the management of recurrent squamous cell head and neck cancer. A GSTTC randomised phase II study. In: European Journal of Cancer. 1993 ; Vol. 29, No. 5. pp. 704-708.
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AU - Paccagnella, Adriano

AU - Pappagallo, Giovanni L.

AU - Segati, Romana

AU - Zorat, Pierluigi

AU - Cavaniglia, Giancarlo

AU - Lunghi, Francesco

AU - Migliorini, Vincenzo

AU - Frattina, Alberto

AU - Bianco, Antonio

AU - Chiarion Sileni, Vanna

AU - Luciana Aversa, Savina M.

AU - Favaretto, Adolfo

AU - Vinante, Orazio

AU - Fiorentino, Mario V.

PY - 1993

Y1 - 1993

N2 - 53 patients with squamous cell carcinoma of the head and neck recurrent after initial treatment were entered into a phase II trial of the epirubicin, methotrexate and bleomycin (EMB) combination. The primary objective of the study was to evaluate the activity of this combination. Compliance to EMB and the possible non-cross-resistance to previous cisplatin-containing chemotherapy were secondary objectives. In order to avoid patient selection bias, the study involved randomisation between EMB and a cisplatin-methotrexate-bleomycin (DMB) combination (with EMB: DMB = 2:1). 23 out of 53 (43% ± 13) EMB patients showed an objective response, lasting a median of 12 (range 4-39) weeks; interestingly, 5 out of 14 (36% ± 25) patients pretreated with cisplatin plus 5-fluorouracil responded to EMB. The treatment compliance was good and a median of three courses was delivered. No patient refused the treatment after the initial cycle. Leukopenia (47%) and oral mucositis (42%) were the main side effects. DMB produced a response rate of 33% ± 18 with a median duration of 5 (4-13) weeks. None of the patients previously treated with cisplatin plus 5-fluorouracil responded. 5 patients refused the treatment after the first cycle and a median of two cycles (0-5) was delivered. In conclusion, EMB produced results similar to cisplatin-containing regimens, with a mild to moderate toxicity and a good compliance; the possible non cross-resistance with cisplatin plus 5-fluorouracil deserves further evaluation.

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