Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical outcome, toxicity and organ/function preservation.

  • Authors:
    • G Mantovani
    • A Maccio
    • E Massa
    • C Mulas
    • M C Mudu
    • S Massidda
    • D Massa
    • V Murgia
    • L Ferreli
    • G Succu
    • G Astara
    • E Proto
    • G Tore
    • M Mura
    • G Maxia
  • View Affiliations

  • Published online on: June 1, 2000     https://doi.org/10.3892/ijo.16.6.1227
  • Pages: 1227-1260
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Abstract

The purpose of the study was to assess response rate, clinical outcome, organ/function preservation and toxicity in head and neck cancer patients treated with induction chemotherapy followed by concomitant chemoradiotherapy and, when necessary, limited surgery. The study design was a phase II non-randomized trial in hospitalized patients setting. The treatment plan consisted of 3 cycles of induction chemotherapy with cisplatin, fluorouracil (5-FU), leucovorin and interferon alpha2b (PFL-IFN) followed by 7 cycles of 5-FU, hydroxyurea and concomitant radiation for 5 days (FHX) for a total radiation dose of 70 Gy. Surgical resection was performed, when necessary, with the intent to spare organ/function. Seventeen patients were treated at one institution. Three patients had stage III and 14 patients stage IV disease. Twelve patients were analyzed for response to PFL-IFN: 2/12 (16.7%) patients achieved a CR and 10/12 (83.3%) achieved a PR for an ORR of 100%. FHX was administered on protocol to 10 patients: 4 patients (40%) had CR, 3 (30%) had PR >/=70% for an ORR of 70%, 1 patient (10%) had SD and 2 patients (20%) had PD. As for local therapy, of the 8 eligible patients who completed chemoradiotherapy, the 3 patients with CR were submitted to random biopsies, results of which were histologically negative, 3 patients with PR >/=70% underwent conservative organ-preserving surgery, and 1 patient with PR >70% refused surgery, whereas the patient with SD underwent salvage surgery, preserving voice. Thus, organ preservation was achieved in all 8 patients at the completion of all therapy: 4 patients had no surgical procedure and 4 patients only conservative surgery. Overall, after completion of all therapy, 5/8 (62.5%) patients were rendered disease-free. The median overall survival time was 23 months, the median duration of response was 6 months and the median time to progression was 9 months. Both induction chemotherapy and concomitant chemoradiotherapy resulted in significant toxicity, which consisted mainly of mucositis and thrombocytopenia. In conclusion, PFL-IFN was very active, producing high ORRs and, followed by FHX, resulted in high overall survival rates permitting an optimal organ preservation, at the cost of a severe toxicity.

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Jun 2000
Volume 16 Issue 6

Print ISSN: 1019-6439
Online ISSN:1791-2423

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Spandidos Publications style
Mantovani G, Maccio A, Massa E, Mulas C, Mudu M, Massidda S, Massa D, Murgia V, Ferreli L, Succu G, Succu G, et al: Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical outcome, toxicity and organ/function preservation.. Int J Oncol 16: 1227-1260, 2000.
APA
Mantovani, G., Maccio, A., Massa, E., Mulas, C., Mudu, M., Massidda, S. ... Maxia, G. (2000). Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical outcome, toxicity and organ/function preservation.. International Journal of Oncology, 16, 1227-1260. https://doi.org/10.3892/ijo.16.6.1227
MLA
Mantovani, G., Maccio, A., Massa, E., Mulas, C., Mudu, M., Massidda, S., Massa, D., Murgia, V., Ferreli, L., Succu, G., Astara, G., Proto, E., Tore, G., Mura, M., Maxia, G."Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical outcome, toxicity and organ/function preservation.". International Journal of Oncology 16.6 (2000): 1227-1260.
Chicago
Mantovani, G., Maccio, A., Massa, E., Mulas, C., Mudu, M., Massidda, S., Massa, D., Murgia, V., Ferreli, L., Succu, G., Astara, G., Proto, E., Tore, G., Mura, M., Maxia, G."Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical outcome, toxicity and organ/function preservation.". International Journal of Oncology 16, no. 6 (2000): 1227-1260. https://doi.org/10.3892/ijo.16.6.1227