Combined postoperative radiotherapy and Weekly Cisplatin infusion for locally advanced head and neck carcinoma: Final report of a randomized trial
Purpose: To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck histological evidence of extracapsular sp...
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Published in | International journal of radiation oncology, biology, physics Vol. 36; no. 5; pp. 999 - 1004 |
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Main Authors | , , , , , |
Format | Journal Article Conference Proceeding |
Language | English |
Published |
New York, NY
Elsevier Inc
01.12.1996
Elsevier |
Subjects | |
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Abstract | Purpose: To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck histological evidence of extracapsular spread of tumor in lymph node metastases(s).
Methods and Materials: Radiotherapy was delivered using a daily dose of 1.7 Gy for the first 54 Gy and 1.8 to 2 Gy until the completion of the treatment. Cisplatin 50 mg i.v. with forced hydratation was given or not every week (i.e., seven to nine cycles) concurrently with radiotherapy. A total of 44 patients were treated by irradiation only (RT group) and 39 by irradiation with chemotherapy (CM group).
Results: The RT group displayed a higher rate of loco-regional failures as compared to CM group (41 vs. 23%; p = 0.08). The overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival were better in CM group as compared to RT group with statistically significant differences. Survival without loco-regional treatment failure was better in the CM group, the difference being close to the level of significance (p = 0.05). Survival without distant metastases were comparable in the two therapeutic groups. Ten severe late complications were observed, four in the RT group (17%) and six in the CM group (22%). Cox univariate analysis comfirned the importance of the therapeutic modality in predicting the overall surviva, the survival corrected for deaths by intercurrent disease, and the disease-free survival.
Conclusions: The present final report of this phase III study confirms preliminary results. The concomitant use of 50 mg weekly Cisplatin infusion and postoperative radiation improved loc-regional control and survival. No significant increase of laet radiation complications was observed in the CM group. |
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AbstractList | To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck and histological evidence of extracapsular spread of tumor in lymph node metastase(s).
Radiotherapy was delivered using a daily dose of 1.7 Gy for the first 54 Gy and 1.8 to 2 Gy until the completion of the treatment. Cisplatin 50 mg i.v. with forced hydratation was given or not every week (i.e., seven to nine cycles) concurrently with radiotherapy. A total of 44 patients were treated by irradiation only (RT group) and 39 by irradiation with chemotherapy (CM group).
The RT group displayed a higher rate of loco-regional failures as compared to CM group (41 vs. 23%; p = 0.08). The overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival were better in CM group as compared to RT group with statistically significant differences. Survival without loco-regional treatment failure was better in the CM group, the difference being close to the level of significance (p = 0.05). Survival without distant metastases were comparable in the two therapeutic groups. Ten severe late complications were observed, four in the RT group (17%) and six in the CM group (22%). Cox univariate analysis confirmed the importance of the therapeutic modality in predicting the overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival.
The present final report of this phase III study confirms preliminary results. The concomitant use of 50 mg weekly Cisplatin infusion and postoperative radiation improved loco-regional control and survival. No significant increase of late radiation complications was observed in the CM group. Purpose: To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck histological evidence of extracapsular spread of tumor in lymph node metastases(s). Methods and Materials: Radiotherapy was delivered using a daily dose of 1.7 Gy for the first 54 Gy and 1.8 to 2 Gy until the completion of the treatment. Cisplatin 50 mg i.v. with forced hydratation was given or not every week (i.e., seven to nine cycles) concurrently with radiotherapy. A total of 44 patients were treated by irradiation only (RT group) and 39 by irradiation with chemotherapy (CM group). Results: The RT group displayed a higher rate of loco-regional failures as compared to CM group (41 vs. 23%; p = 0.08). The overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival were better in CM group as compared to RT group with statistically significant differences. Survival without loco-regional treatment failure was better in the CM group, the difference being close to the level of significance (p = 0.05). Survival without distant metastases were comparable in the two therapeutic groups. Ten severe late complications were observed, four in the RT group (17%) and six in the CM group (22%). Cox univariate analysis comfirned the importance of the therapeutic modality in predicting the overall surviva, the survival corrected for deaths by intercurrent disease, and the disease-free survival. Conclusions: The present final report of this phase III study confirms preliminary results. The concomitant use of 50 mg weekly Cisplatin infusion and postoperative radiation improved loc-regional control and survival. No significant increase of laet radiation complications was observed in the CM group. |
Author | Cohen-Jonathan, Elizabeth Alzieu, Claude David, Jean-Marc Bachaud, Jean-Marc Daly-Schveitzer, Nicolas Serrano, Elie |
Author_xml | – sequence: 1 givenname: Jean-Marc surname: Bachaud fullname: Bachaud, Jean-Marc organization: Department of Radiotherapy, Centre Claudius Regaud, 20-24 rue du Pont Saint-Pierre, Toulouse Cedex, France – sequence: 2 givenname: Elizabeth surname: Cohen-Jonathan fullname: Cohen-Jonathan, Elizabeth organization: Department of Radiotherapy, Centre Claudius Regaud, 20-24 rue du Pont Saint-Pierre, Toulouse Cedex, France – sequence: 3 givenname: Claude surname: Alzieu fullname: Alzieu, Claude organization: Department of Radiotherapy, Centre Claudius Regaud, 20-24 rue du Pont Saint-Pierre, Toulouse Cedex, France – sequence: 4 givenname: Jean-Marc surname: David fullname: David, Jean-Marc organization: Department of Head and Neck Surgery, Centre Claudius Regaud, 20-24 rue du Pont Saint-Pierre, Toulouse Cedex, France – sequence: 5 givenname: Elie surname: Serrano fullname: Serrano, Elie organization: Department of Head and Neck Surgery, Centre Hospitalier Universitaire Rangueil, Chemin du Vallon, Toulouse, France – sequence: 6 givenname: Nicolas surname: Daly-Schveitzer fullname: Daly-Schveitzer, Nicolas organization: Department of Radiotherapy, Centre Claudius Regaud, 20-24 rue du Pont Saint-Pierre, Toulouse Cedex, France |
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Keywords | Combination chemotherapy-radiotherapy Head and neck cancer Radiosensitization Radiotherapy Cisplatin Human Postoperative Squamous cell carcinoma Treatment efficiency Malignant tumor Chemotherapy Weekly Head and neck ENT disease Advanced stage Combined treatment Survival curve Platinum II Complexes |
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PublicationDateYYYYMMDD | 1996-12-01 |
PublicationDate_xml | – month: 12 year: 1996 text: 1996-12-01 day: 01 |
PublicationDecade | 1990 |
PublicationPlace | New York, NY |
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PublicationTitle | International journal of radiation oncology, biology, physics |
PublicationTitleAlternate | Int J Radiat Oncol Biol Phys |
PublicationYear | 1996 |
Publisher | Elsevier Inc Elsevier |
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Snippet | Purpose: To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy... To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and... |
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SubjectTerms | Antineoplastic agents Antineoplastic Agents - therapeutic use Biological and medical sciences Carcinoma, Squamous Cell - mortality Carcinoma, Squamous Cell - therapy Cisplatin Cisplatin - therapeutic use Combination chemotherapy-radiotherapy Combined Modality Therapy Combined treatments (chemotherapy of immunotherapy associated with an other treatment) Head and neck cancer Head and Neck Neoplasms - mortality Head and Neck Neoplasms - therapy Humans Medical sciences Neoplasm Recurrence, Local Pharmacology. Drug treatments Prospective Studies Radiosensitization Radiotherapy Regression Analysis |
Title | Combined postoperative radiotherapy and Weekly Cisplatin infusion for locally advanced head and neck carcinoma: Final report of a randomized trial |
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