Re-Irradiation Combined With Chemotherapy After Salvage Surgery for Head and Neck Cancer Improves Progression-Free Survival Rates, Not Overall Survival Rates
- Barcelona, Spain
- Bruce Sylvester
- Doctor’s Guide (www.docguide.com)
Re-irradiation combined with chemotherapy after salvage surgery improves progression-free survival rates in patients with head and neck cancer but does not affect their overall survival rate, researchers report.
“In this first randomised trial on the subject, we found that this combination treatment can indeed improve disease-free survival after salvage surgery, but we note that there was no effect on overall survival,” said investigator and presenter Dominique de Raucourt, MD, radiologist, Centre Francois Baclesse, Caen, France.
Dr. de Raucourt presented the results in an oral session here on February 24th at the International Meeting on Innovative Approaches in Head and Neck Oncology. The meeting was co-sponsored by the European Head and Neck Society (EHNS) and the European Society for Therapeutic Radiology and Oncology (ESTRO).
The investigators enrolled 130 head and neck cancer patients who had been treated with salvage surgery. Patients were randomised to receive either full dose re-irradiation combined with chemotherapy (arm A) or no postoperative treatment after the salvage surgery (arm B).
Eligibility for enrolment included the following criteria: recurrence of disease or appearance of second primary cancer site in a previously irradiated area (up to at least 45 Gy); absence of distant metastasis; salvage surgery with macroscopic complete resection; possibility of starting adjuvant treatment within 6 weeks after salvage surgery.
Subjects in arm A received 60 Gy radiation within 12 weeks combined with concomitant 5-fluorouracil (5FU) and hydroxyurea.
After the end of the trial the 29 surviving subjects who did not have carcinological events completed European Organisation for Research and Treatment of Cancer quality of life questionnaires (QLQ-C30 and QLQ H&N35).
Sixty-five subjects were randomised to each arm of the trial, including 71% having local and/or regional relapse and 29% having a second primary site of disease. Age, sex, tumour site, tumour depth of invasion (T) and staging of regional lymph nodes (N) restaging and histological gravity signs were all balanced between the 2 arms.
The investigators found that the most important acute toxicity related to re-irradiation was mucositis grade 3 or 4 in 29% of subjects. They also reported a grade 3 or 4 Radiation Therapy Oncology Group late toxicity (trismus, mucosa, fibrosis) in 40% of arm A subjects and in 10% of arm B subjects.
In addition, progression-free survival was significantly improved in arm A with a hazard ratio of 1.6 (P =.01), “but overall survival was not statistically different,” they noted.
For the 20 subjects who finished the questionnaires, global health was similar in both arms of the trial.
The authors concluded, “This is the first randomised trial to evaluate the effect of full dose re-irradiation combined with chemotherapy after salvage surgery. The results showed that re-irradiation and chemotherapy were able to significantly improve progression-free survival, with no significant impact on overall survival and acceptable quality of life among surviving patients.”
Presentation title: Randomised Trial of Re-Irradiation Combined With Chemotherapy After Salvage Surgery in Head and Neck Carcinoma: Carcinologic And Quality of Life Results GETTEC and GORTEC Groups. Abstract 55