Randomized trial comparing two methods of re-irradiation after salvage surgery in head and neck squamous cell carcinoma: Once daily split-course radiotherapy with concomitant chemotherapy or twice daily radiotherapy with cetuximab.

BACKGROUND: A previous randomized trial in recurrent Head and Neck squamous-cell carcinoma (HNSCC) has shown re-irradiation combined with chemotherapy after salvage surgery significantly improved disease-free survival (DFS). The objective of this randomized trial was to compare two methods of re-irradiation in terms of toxicity and survival. PATIENTS AND METHODS: Patients with recurrence/second primary in previously irradiated area were randomly allocated to receive either 60 Gy over 11 weeks with concomitant 5FU - hydroxyurea (VP-arm), or 60 Gy (1.2 Gy twice daily) over 5 weeks with cetuximab (HFR-arm). Primary endpoint was treatment interruption >15 days (acute toxicity). RESULTS: Twenty-six patients were included in VP-arm and 27 in HFR-arm. One patient in VP-arm experienced >15 days interruption due to toxicity, and none in HFR-arm. In both arms, all patients received at least 60 Gy. In VP-arm, 8/26 patients had chemotherapy delay and/or dose reduction. In HFR-arm, 4/27 patients had <6 cycles cetuximab. There was no significant difference in overall survival (Median OS: 37.4 months vs 21.9 months, p = 0.12). Toxicities and DFS were not different between 2 arms. CONCLUSIONS: Twice daily schedule of re-irradiation of 60 Gy/5 weeks with cetuximab was tolerable and no significant difference in treatment delays occurred between two arms.

Impact of 3D conformal radiotherapy on lung function of patients with lung cancer: a prospective study.

BACKGROUND: The development of three-dimensional conformal radiotherapy (3D-RT) has enabled the restriction of the dose to normal lung, limiting radiation-induced lung injury. OBJECTIVES: This study was designed to describe the time course of lung function until 7.5 months after 3D-RT in patients with lung cancer, and assess the relationship between lung function changes and dose-volume histogram (DVH) analysis or computed tomography scan changes. Radiation doses were optimized according to recent guidelines. METHODS: Sixty-five lung cancer patients treated with 3D-RT agreed to participate in this prospective, hospital-based study. Lung volumes, forced expiratory volume in 1 s (FEV1) and diffusing capacity of the lung for carbon monoxide (DLCO) were measured before radiotherapy (RT), 10 weeks, 4 and 7.5 months after the beginning of 3D-RT. RESULTS: Eleven lung cancer patients (17%) developed grade 2-3 respiratory symptoms after RT. At 7.5 months, vital capacity (VC) was 96 ± 2%, total lung capacity (TLC) 95 ± 2%, FEV1 93 ± 2% and DLCO 90 ± 2% of the initial value. Only 15% of patients showed pulmonary function reduction > 20%. Patients with FEV1 or DLCO < 60% before RT did not show significant changes after RT. There were weak correlations between reduction of VC, TLC, FEV1 or DLCO and radiation dosimetric parameters and between reduction of VC or FEV1 and radiation-induced pneumonitis images. CONCLUSIONS: In lung cancer, the reduction of lung function within 7.5 months after 3D-RT was small and correlated, albeit weakly, with DVH parameters. Patients with initially impaired lung function showed tiny changes in spirometry and DLCO values.

Prognostic factors of survival in head and neck cancer patients treated with surgery and postoperative radiation therapy.

CONCLUSIONS: Given that radiation therapy (RT) is currently initiated as soon as possible after surgery, our results indicate that the main prognostic factors of survival are pT and pN stages in patients treated with surgery and postoperative RT for locally advanced head and neck squamous cell carcinoma (HNSCC). OBJECTIVES: To determine the prognostic factors for survival in patients treated with surgery and postoperative RT for locally advanced HNSCC. PATIENTS AND METHODS: A retrospective study was performed on 308 consecutive patients treated from 1990 to 1998 with surgery and postoperative RT. In addition to histological factors, time-related factors were considered. RESULTS: The median age of the whole cohort was 56 years (range 35-83). Median follow-up was 98 months. Median interval from surgery to the start of RT was 44 days (range 18-157), while median RT duration was 52 days (range 22-115). From univariate analysis of overall survival, statistically significant prognostic factors were pT stage (p<0.0001), pN stage (p=0.008), RT duration (p=0.01) and total treatment time (p=0.02). Perineural invasion, perivascular invasion, extranodal spread and positive resection margins did not appear to be related to survival. From multivariate analysis, the only statistically independent prognostic factors appeared to be pT and pN stages.

Prognostic indicators for survival in head and neck squamous cell carcinomas: analysis of a series of 621 cases.

BACKGROUND: We sought to study the influence of pT classification, pN status, tumor volume, and number of lymph nodes invaded on survival of patients with head and neck cancers to improve therapeutic indications. METHODS: This was a retrospective study of 621 consecutive patients treated from 1990 to 1997 by a single team. RESULTS: In univariate analysis, pT classification (p < .0001), pN status (p < .0001), capsule rupture (p < .0001), the number of lymph nodes invaded (0, 1-3, 4-9, > or =10) (p < .0001), and the tumor volume (p < .0001) were significantly associated with overall survival. A Cox model identified as independent prognostic indicators age (p < .0001), pT classification (p < .0001), and pN status (p < .0001). CONCLUSIONS: Not only pT classification and pN status but also the number of the lymph nodes invaded and the tumor volume should be considered as essential prognostic indicators, and any clinical trial developed should stratify accordingly.