Precise reporting of surgical staging and operative data in multi-institutional protocol studies could provide a number of benefits: 1) fewer cases would be discarded because of inadequate data, 2) staff review time would be reduced, 3) there would be assurance that participating surgeons were performing similar operations on similar tumors, 4) the resulting precision in stratification should improve the likelihood of achieving accurate comparison of the treatment options under study, and 5) by comparing the surgical parameters with local-regional control of disease, the specific factors that have a statistically significant correlation with outcome could be identified. This paper presents a computer-based, anatomically oriented reporting instrument that should improve the reliability of surgical data available to multi-institutional protocols.

Since its foundation in 1971, the RTOG has conducted a successful clinical research program in head and neck mucosal squamous cell carcinoma with 22 treatment protocols and one registry study which combined have accumulated data on over 5,500 patients. The RTOG was the first multicenter group to evaluate neoadjuvant chemotherapy before definitive radiation with its methotrexate study. Although the study was negative, RTOG has since conducted five pilot or phase II studies of neoinduction or concurrent chemotherapy with radiation therapy in patients with inoperable tumors. The last study showed that radiation concurrent with cisplatinum was tolerable with a suggestion of increased antitumor effect. In patients with potentially resectable tumors, RTOG has completed a pilot study of combination chemotherapy administered either before or after the surgery with radiotherapy. Based upon its findings, the treatment sequence, surgery-chemotherapy-radiotherapy, was chosen as the experimental arm for a new phase III study. This study was subsequently adopted by the head and neck intergroup mechanism as its study (INT 0034/RTOG 8503). RTOG has investigated the optimal timing of radiotherapy with surgery. The 7303 study established that postoperative radiotherapy achieved significantly better locoregional control but not improved absolute survival. Approximately 30% of the patients on each arm failed to complete both modalities. Even when comparison is restricted to patients who completed both modalities, postoperative radiotherapy still produced the better locoregional control. Efforts to overcome the limitations imposed by tumor hypoxia through use of carbogen (95% O2 and 5% CO2) breathing or the radiosensitizer misonidazole during radiotherapy have been unsuccessful. In a phase I study, RTOG showed that 15 to 18 sessions of sensitized radiation can be safely delivered with the new radiosensitizer SR 2508 in contrast to only six such sessions with misonidazole. This promising radiosensitizer is now being tested in a phase III trial. RTOG has also investigated variations in fraction size, fraction number, and total radiation dose. In the 7102 study, split-course irradiation achieved equivalent antitumor results as compared to continuous daily irradiation but with less social alteration and cost to the patient. In the hyperfraction pilot study 7703, twice a day irradiation with 120 cGys up to 6,000 cGys proved to be tolerable.(ABSTRACT TRUNCATED AT 400 WORDS)

Effective treatment modalities for Stage III and IV squamous cell carcinomas (SCC) of the head and neck are limited and seldom result in long term survival. The improved results with cisplatin containing chemotherapy have been encouraging and represent an additional therapeutic modality for head and neck cancer. To estimate the effectiveness of concomitant radiation and cisplatin chemotherapy, the Radiation Therapy Oncology Group (RTOG) initiated a Phase II study for patients with advanced nonresectable SCC of the head and neck. In addition, the diagnostic biopsy specimens were collected. Two pathologists reviewed and scored the biopsy specimens for a number of histologic parameters, including degree of keratinization, nuclear pleomorphism, frequency of mitoses, inflammatory and stromal reaction, pattern of invasion and vascular involvement in order to identify potential prognostically important patient subgroups. A total of 114 patients were evaluated for complete clinical responses (CR). These were achieved in 76% for all head and neck sites (ALL), and in 72% of the patients excluding nasopharyngeal and sinus cancers (REST). Evaluation of histopathologic parameters through multivariate analysis identified the presence of keratin as the most significant in predicting CR. Non-keratinizing SCC had CRs of 98% (ALL), and 94% (REST), as compared with 64% and 67% in the patients with keratin producing neoplasms (P less than 0.001 and 0.05) respectively. Survival at 24 months was found to be improved in the non-keratinizing SCC (P = 0.002). Multivariate analysis also identified the frequency of mitoses as being important in predicting for CR in patients with keratin in the biopsy findings. Biopsy specimens from ALL patients with two or more mitotic figures per high-power microscopic field had 76% CRs, in comparison with 46% when none or one mitotic figure was observed (P = 0.02). In the restricted group of patients (REST), the CR was 77% in the high mitotic figure group as opposed to 45% in the lower rate group (P = 0.03). However, this significant difference in CR rates did not translate into improved survival for the high CR subset.