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Clinical Trial
. 1995 Jul-Aug;90(1-2):94-101.

[Combined chemo-radiotherapy in non-operable cervico-facial neoplasms. Final results of an experience with non-selected patients]

[Article in Italian]
Affiliations
  • PMID: 7569105
Clinical Trial

[Combined chemo-radiotherapy in non-operable cervico-facial neoplasms. Final results of an experience with non-selected patients]

[Article in Italian]
L Pirtoli et al. Radiol Med. 1995 Jul-Aug.

Abstract

The management of advanced inoperable head and neck cancer is often based on a combined chemo-radiotherapy approach. No definitive conclusions on the effectiveness of this combination can be drawn from clinical trials because these neoplasms are heterogeneous and treatment schedules vary. Many scientific trials test highly toxic combinations, whereas not only good results but also low toxicity are mandatory in the current practice. We report the results obtained in 90 consecutive patients affected with inoperable head and neck cancers in stages III-IV, or relapsed after surgery. Chemotherapy consisted of a cis-platinum/bleomycin induction phase, followed by weekly administrations of cis-platinum simultaneous with conventional irradiation. The objective remission rates, achieved at the end of the induction chemotherapy and the simultaneous chemo-radiotherapy phases, were respectively 55.5% and 84.5%. The tumor disappeared in 39% of cases, by the end of the whole treatment. With the Kaplan-Meier method, 3-year overall, progression-free and relapse-free survival rates were 21.20%, 22.25% and 38.75%, respectively. The overall survival rate, calculated with the "log-rank" test according to the stage and the site of the primary tumor, exhibited no significant differences. In contrast, significant differences (p < 0.05) were demonstrated, according to treatment intent (curative radical: 26%, vs palliative: 0%) and to the achievement of an objective response at the end of induction chemotherapy--i.e., 48% 3-year survival rate, vs 7% in chemotherapy resistant cancer patients. When limiting the analysis to 72 radically irradiated patients, however, the achievement of CR after induction chemotherapy lost its prognostic value. Toxicity was not substantially higher than with conventional irradiation. Our results are in agreement with literature data on this subject which, regarding survival, fail to prove such integrated treatments as ours better than irradiation alone. In contrast, the preliminary combination of chemotherapy and irradiation is clearly better for the patients waiting to receive radiation therapy, because tumor volume and related symptoms markedly decrease after induction chemotherapy. Currently the best survival rates (about 50% at 3 years) with chemo-radiotherapy are obtained, in this kind of cancer, by combining cis-platinum and continuous-infusion 5-fluorouracil, simultaneous with irradiation. However, frequent and severe toxicity is reported. Should such a modality be adopted in the current practice, patients should be selected according to their medical conditions.

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