Bleomycin, Methotrexate, and CCNU in Locally Advanced or Recurrent, Inoperable, Squamous-Cell Carcinoma of the Vulva: An EORTC Gynaecological Cancer Cooperative Group Study
Articolo
Data di Pubblicazione:
2001
Citazione:
Bleomycin, Methotrexate, and CCNU in Locally Advanced or
Recurrent, Inoperable, Squamous-Cell Carcinoma of the Vulva: An
EORTC Gynaecological Cancer Cooperative Group Study / H.C. Wagenaar, N. Colombo, I. Vergote, G. Hoctin-Boes, G. Zanetta, S. Pecorelli, A.J. Lacave, Q. Van Hoesel, A. Cervantes, G. Bolis, M. Namer, C. Lhomme´, J.P. Guastalla, M.A. Nooij, A. Poveda,
V. Scotto di Palumbo, J. B. Vermorken. - In: GYNECOLOGIC ONCOLOGY. - ISSN 0090-8258. - 81:3(2001 Jun), pp. 348-354. [10.1006/gyno.2001.6180]
Abstract:
Objectives. To investigate tumor response rate and treatment
toxicity of a modified combination chemotherapy consisting of
bleomycin (B), methotrexate (M), and CCNU (C) for patients with
locally advanced, squamous-cell carcinoma of the vulva (not amenable
to resection by standard radical vulvectomy) or recurrent
disease (after incomplete resection). Tumor resectability was reassessed
in patients who had responded to chemotherapy.
Methods. The regimen consisted of bleomycin 5 mg intramuscular
(im) days 1–5, CCNU 40 mg per os (po) days 5–7, and
methotrexate 15 mg po days 1 and 4 during the first week. During
weeks 2–6 the patient was administered bleomycin 5 mg im days
1 and 4, and methotrexate 15 mg po on day 1 of the week. This
6-week cycle was repeated at 49-day intervals.
Results. Twenty-five eligible patients with a median age of 66
years (range, 39–82 years) were entered in this phase II trial.
Twelve patients had primary locally advanced disease, 13 patients
had a locoregional recurrence, and all received up to three BMC
cycles. Two complete and twelve partial responses were observed
(response rate, 56%; 95% confidence limits, 35–76%). The BMC
regimen was associated with major hematological side effects and
mild signs of bleomycin-related pulmonary toxicity. At a median
follow-up of 8 months, 3 patients were alive, 18 had died due to
malignant disease, 2 had died due to toxicity, and 2 had died due
to intercurrent disease and unknown cause. The median progression-
free survival was 4.8 months and the median survival was 7.8
months. The 1-year survival was 32% (95% confidence limits,
13–51%).
Conclusion. The present data confirm the therapeutic activity of
the BMC regimen in locoregionally advanced or recurrent squamous-
cell carcinoma of the vulva. Following neoadjuvant chemotherapy,
the overall response rate was 56%. BMC is an outpatient
treatment that may play a role in the palliative therapy of advanced
or recurrent vulva cancer.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
vulva ; cancer ; phase II trial ; chemotherapy ; bleomycin ;
methotrexate ; CCNU
Elenco autori:
H.C. Wagenaar, N. Colombo, I. Vergote, G. Hoctin-Boes, G. Zanetta, S. Pecorelli, A.J. Lacave, Q. Van Hoesel, A. Cervantes, G. Bolis, M. Namer, C. Lhomme´, J.P. Guastalla, M.A. Nooij, A. Poveda,
V. Scotto di Palumbo, J. B. Vermorken
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