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 language | English |
|---|---|
| Pages (from-to) | 704-708 |
| Number of pages | 5 |
| Journal | European Journal of Cancer |
| Volume | 29 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 1993 |
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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 journal › Article
}
TY - JOUR
T1 - Epirubicin, methotrexate and bleomycin in the management of recurrent squamous cell head and neck cancer. A GSTTC randomised phase II study
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0027405889&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0027405889&partnerID=8YFLogxK
U2 - 10.1016/S0959-8049(05)80350-8
DO - 10.1016/S0959-8049(05)80350-8
M3 - Article
VL - 29
SP - 704
EP - 708
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
IS - 5
ER -