A randomized phase II study comparing sequential versus simultaneous chemo-radiotherapy in patients with unresectable locally advanced squamous cell cancer of the head and neck

P. Pinnarò, M. C. Cercato, D. Giannarelli, P. Carlini, M. R del Vecchio, F. Ambesi Impiombato, F. Marzetti, M. Milella, F. Cognetti

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Abstract

Background: Single-modality radiotherapy is still considered standard treatment for patients with locally advanced unre-sectable cancer of the head and neck. As treatment outcome is poor, attempts to integrate chemotherapy into the overall management of these patients are ongoing. Patients and methods: A randomized study was undertaken to compare a sequential with a simultaneous chemo-radiotherapy program. Between February 1986 and February 1991, 93 eligible patients with locally advanced unresect-able cancer of the head and neck were stratified by WHO PS, T and N class and primary site and then randomized to receive either three courses of neoadjuvant chemotherapy with cisplatin (100 mg/m2 i.v. d 1) and 5-fluorouracil 1000 mg/ m2days 1-5 by continuous i.v. infusion every 3 weeks prior to definitive conventional radiotherapy of 65-70 Gy (sequential treatment), or cisplatin 100 mg/m2 on days 1,22,43 given simultaneously for the duration of the same conventional radiotherapy (simultaneous treatment). Results: At the end of the entire treatment 18 complete responses (47%) in the sequential-treatment arm and 18 (41%) in the simultaneous treatment arm were obtained. No statistically significant differences in the 5-yr progression-free survival, in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed. Leukopenia was more frequent in the simultaneous than in the sequential arm (p = 0.03), whereas alopecia (p = 0.008) and phlebitis (p <0.0001) were more frequent in the sequential-treatment arm. A better compliance was associated with the concomitant treatment, with 87% of the patients completing the entire radiotherapy program versus 63% of those in the sequential arm (p = 0.01). Conclusions: In the present study, the two treatment arms showed similar activity (complete response, progression-free and overall survival rates). Compliance to treatment was better in the concomitant arm. These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck. Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone.

Original languageEnglish
Pages (from-to)513-519
Number of pages7
JournalAnnals of Oncology
Volume5
Issue number6
Publication statusPublished - Jul 1994

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Chemoradiotherapy
Squamous Cell Neoplasms
Radiotherapy
Head and Neck Neoplasms
Cancer
Cell
Cisplatin
Chemotherapy
Progression
Therapeutics
Disease-Free Survival
Compliance
Epithelial Cells
Entire
Phlebitis
Drug Therapy
Radiation Therapy
Alopecia
Leukopenia
Fluorouracil

Keywords

  • Chemo-radiotherapy
  • Head and neck squamous cell cancer

ASJC Scopus subject areas

  • Statistics, Probability and Uncertainty
  • Applied Mathematics
  • Public Health, Environmental and Occupational Health
  • Neuropsychology and Physiological Psychology
  • Hematology
  • Oncology
  • Cancer Research

Cite this

@article{26210ae90ce144d79896d276086c255b,
title = "A randomized phase II study comparing sequential versus simultaneous chemo-radiotherapy in patients with unresectable locally advanced squamous cell cancer of the head and neck",
abstract = "Background: Single-modality radiotherapy is still considered standard treatment for patients with locally advanced unre-sectable cancer of the head and neck. As treatment outcome is poor, attempts to integrate chemotherapy into the overall management of these patients are ongoing. Patients and methods: A randomized study was undertaken to compare a sequential with a simultaneous chemo-radiotherapy program. Between February 1986 and February 1991, 93 eligible patients with locally advanced unresect-able cancer of the head and neck were stratified by WHO PS, T and N class and primary site and then randomized to receive either three courses of neoadjuvant chemotherapy with cisplatin (100 mg/m2 i.v. d 1) and 5-fluorouracil 1000 mg/ m2days 1-5 by continuous i.v. infusion every 3 weeks prior to definitive conventional radiotherapy of 65-70 Gy (sequential treatment), or cisplatin 100 mg/m2 on days 1,22,43 given simultaneously for the duration of the same conventional radiotherapy (simultaneous treatment). Results: At the end of the entire treatment 18 complete responses (47{\%}) in the sequential-treatment arm and 18 (41{\%}) in the simultaneous treatment arm were obtained. No statistically significant differences in the 5-yr progression-free survival, in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed. Leukopenia was more frequent in the simultaneous than in the sequential arm (p = 0.03), whereas alopecia (p = 0.008) and phlebitis (p <0.0001) were more frequent in the sequential-treatment arm. A better compliance was associated with the concomitant treatment, with 87{\%} of the patients completing the entire radiotherapy program versus 63{\%} of those in the sequential arm (p = 0.01). Conclusions: In the present study, the two treatment arms showed similar activity (complete response, progression-free and overall survival rates). Compliance to treatment was better in the concomitant arm. These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck. Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone.",
keywords = "Chemo-radiotherapy, Head and neck squamous cell cancer",
author = "P. Pinnar{\`o} and Cercato, {M. C.} and D. Giannarelli and P. Carlini and Vecchio, {M. R del} and Impiombato, {F. Ambesi} and F. Marzetti and M. Milella and F. Cognetti",
year = "1994",
month = "7",
language = "English",
volume = "5",
pages = "513--519",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "NLM (Medline)",
number = "6",

}

TY - JOUR

T1 - A randomized phase II study comparing sequential versus simultaneous chemo-radiotherapy in patients with unresectable locally advanced squamous cell cancer of the head and neck

AU - Pinnarò, P.

AU - Cercato, M. C.

AU - Giannarelli, D.

AU - Carlini, P.

AU - Vecchio, M. R del

AU - Impiombato, F. Ambesi

AU - Marzetti, F.

AU - Milella, M.

AU - Cognetti, F.

PY - 1994/7

Y1 - 1994/7

N2 - Background: Single-modality radiotherapy is still considered standard treatment for patients with locally advanced unre-sectable cancer of the head and neck. As treatment outcome is poor, attempts to integrate chemotherapy into the overall management of these patients are ongoing. Patients and methods: A randomized study was undertaken to compare a sequential with a simultaneous chemo-radiotherapy program. Between February 1986 and February 1991, 93 eligible patients with locally advanced unresect-able cancer of the head and neck were stratified by WHO PS, T and N class and primary site and then randomized to receive either three courses of neoadjuvant chemotherapy with cisplatin (100 mg/m2 i.v. d 1) and 5-fluorouracil 1000 mg/ m2days 1-5 by continuous i.v. infusion every 3 weeks prior to definitive conventional radiotherapy of 65-70 Gy (sequential treatment), or cisplatin 100 mg/m2 on days 1,22,43 given simultaneously for the duration of the same conventional radiotherapy (simultaneous treatment). Results: At the end of the entire treatment 18 complete responses (47%) in the sequential-treatment arm and 18 (41%) in the simultaneous treatment arm were obtained. No statistically significant differences in the 5-yr progression-free survival, in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed. Leukopenia was more frequent in the simultaneous than in the sequential arm (p = 0.03), whereas alopecia (p = 0.008) and phlebitis (p <0.0001) were more frequent in the sequential-treatment arm. A better compliance was associated with the concomitant treatment, with 87% of the patients completing the entire radiotherapy program versus 63% of those in the sequential arm (p = 0.01). Conclusions: In the present study, the two treatment arms showed similar activity (complete response, progression-free and overall survival rates). Compliance to treatment was better in the concomitant arm. These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck. Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone.

AB - Background: Single-modality radiotherapy is still considered standard treatment for patients with locally advanced unre-sectable cancer of the head and neck. As treatment outcome is poor, attempts to integrate chemotherapy into the overall management of these patients are ongoing. Patients and methods: A randomized study was undertaken to compare a sequential with a simultaneous chemo-radiotherapy program. Between February 1986 and February 1991, 93 eligible patients with locally advanced unresect-able cancer of the head and neck were stratified by WHO PS, T and N class and primary site and then randomized to receive either three courses of neoadjuvant chemotherapy with cisplatin (100 mg/m2 i.v. d 1) and 5-fluorouracil 1000 mg/ m2days 1-5 by continuous i.v. infusion every 3 weeks prior to definitive conventional radiotherapy of 65-70 Gy (sequential treatment), or cisplatin 100 mg/m2 on days 1,22,43 given simultaneously for the duration of the same conventional radiotherapy (simultaneous treatment). Results: At the end of the entire treatment 18 complete responses (47%) in the sequential-treatment arm and 18 (41%) in the simultaneous treatment arm were obtained. No statistically significant differences in the 5-yr progression-free survival, in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed. Leukopenia was more frequent in the simultaneous than in the sequential arm (p = 0.03), whereas alopecia (p = 0.008) and phlebitis (p <0.0001) were more frequent in the sequential-treatment arm. A better compliance was associated with the concomitant treatment, with 87% of the patients completing the entire radiotherapy program versus 63% of those in the sequential arm (p = 0.01). Conclusions: In the present study, the two treatment arms showed similar activity (complete response, progression-free and overall survival rates). Compliance to treatment was better in the concomitant arm. These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck. Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone.

KW - Chemo-radiotherapy

KW - Head and neck squamous cell cancer

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