This Article Full Text (PDF) eLetters: Submit a response to this article Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article link to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Segura, A. Articles by Aparicio, J. Search for Related Content PubMed PubMed Citation Articles by Segura, A. Articles by Aparicio, J.

Cisplatin Plus Vinorelbine for Patients with Advanced Head and Neck Squamous Cell Carcinoma

Department of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain

Correspondence: Angel Segura, M.D., Servicio de Oncología Médica, Hospital Universitario La Fe, Avda. Campanar 21, E-46009 Valencia, Spain. Telephone and Fax: 34-96-398-73-55.

We have read with interest the article by Degardin et al. [1] recently published. The authors reported a 16% response rate for vinorelbine (VNR) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The main toxicity was hematological, with a 53% incidence of grade 3-4 neutropenia. These results are similar to those published by other groups using VNR monotherapy for these patients [2, 3]. They concluded that VNR is active enough to assess its combination with other drugs.

Due to non-overlapping toxicity profiles and theoretical synergism data, cisplatin (CDDP) and VNR have been combined for the treatment of non-small cell lung cancer, with a demonstrated security profile [4]. Our group has performed two sequential studies of CDDP (100 mg/m²/day 1) plus VNR (30 mg/m²/days 1, 8), with courses repeated every 21 days, for patients with advanced or recurrent head and neck carcinoma. Twenty-seven patients (previously treated with radiation, surgery and/or chemotherapy) were included in a phase II trial [5]. Five patients were previously treated with chemotherapy, four with CDDP plus 5-fluorouracil and one with methotrexate. We achieved complete responses in 18% and partial responses in 30% (overall response rate of 48%); two of the patients treated with CDDP plus 5-fluorouracil have a partial response. The main toxicity was grade 3-4 neutropenia (56% patients). There were two deaths due to toxicity, both associated with grade 4 neutropenia. Median survival was 12 months and two-year survival was 33%.

In 1996 we initiated a comparative study of CDDP-VNR (arm A) versus the classical combination of CDDP and 120-h continuous infusion of 5-fluorouracil [6] (arm B). Both treatment protocols were used as neoadjuvant therapy for patients with initially non-resectable disease (three courses were projected before surgery and/or radiotherapy). Preliminary results involving 26 patients (13 in each arm) have been published [7]. The response rate was equal in both arms (overall responses of 69%). After induction treatment, 12 patients have received irradiation, seven surgery plus irradiation, while seven did not complete the projected therapy (four due to tumor progression, three due to toxicity). The toxicity profiles were different: myelotoxicity was more common in arm A, whereas digestive toxicity was more frequent in arm B. One patient in arm A and two patients in arm B have died from toxic complications of therapy. At the time of analysis, ten patients were alive in arm A (six disease-free) and eight in arm B (five disease-free). The study is ongoing, and 39 patients have been included to date. Table 1 shows a summary of all patients treated with CDDP-VNR in both studies.

References

1. Degardin M, Oliveira J, Geoffrois L et al. An EORTC-ECSG phase II study of vinorelbine in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Ann Oncol 1998;9:1103-1107.[Abstract/Free Full Text]
2. Gebbia V, Testa A, Valeza R et al. A pilot study of vinorelbine on a weekly schedule in recurrent and/or metastatic squamous-cell-carcinoma of the head and neck. Eur J Cancer 1993;29:1358-1359.[CrossRef]
3. Testolin A, Recher G, Gristoferi V et al. Vinorelbine in pretreated advanced head and neck squamous-cell-carcinoma. A phase II study. Invest New Drugs 1994;12:231-234.[CrossRef][Medline]
4. Le Chevalier T, Brisgand D, Douillard JY et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non small cell lung cancer: results of a European multicentric trial including 612 patients. J Clin Oncol 1994;12:360-367.[Abstract]
5. Segura A, Pastor M, Garcerá S et al. Quimioterapia con cisplatino y vinorelbina en pacientes con tumores de cabeza cuello avanzados. Oncología 1998;21:421-427.
6. Kish J, Drelichman A, Jacobs J et al. Clinical trial of cisplatin and 5-fluorouracil infusion as initial treatment for advanced squamous cell carcinoma of the head and neck. Cancer Treat Rep 1982;66:471-474.[Medline]
7. Segura A, Pastor M, Garcerá S et al. Cisplatin plus 5-fluorouracil vs cisplatin plus vinorelbine for patients with locally advanced head and neck cancer. Preliminary results of a randomized trial. In: Alvarez Vicent JJ, ed. First World Congress on Head and Neck Oncology. Bologna: Monduzzi Editore, 1998:1011-1016.

This Article Full Text (PDF) eLetters: Submit a response to this article Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article link to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints/Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Segura, A. Articles by Aparicio, J. Search for Related Content PubMed PubMed Citation Articles by Segura, A. Articles by Aparicio, J.