Researchers involved in the RTOG 0024 study have reported that the administration of early adjuvant Taxol® (paclitaxel) followed by concurrent chemoradiotherapy may improve local control and improve disease-free survival in patients with high-risk head and neck carcinoma. The details of this study appeared in the Journal of Clinical Oncology early online on August 31, 2009.
There have been several randomized and non-randomized clinical trials that suggest that the concomitant administration of platinum-based chemotherapy and radiotherapy (RT) is superior to RT alone for the treatment of patients with advanced head and neck cancer for local and regional control. Most, but not all, have also shown a survival advantage for combined treatment.
An intergroup trial with participation of RTOG, ECOG, and SWOG compared post-operative radiotherapy alone or with concurrent Platinol® (cisplatin) for patients with high-risk head and neck cancer. This study showed that the addition of adjuvant Platinol decreased local recurrences but had no significant impact on metastatic disease or overall survival. An EORTC trial showed that the addition of Platinol to RT improved progression-free and overall survival by 10% and improved overall survival by the same degree.
The current study (RTOG 0024) sought to improve the results of adjuvant chemoradiotherapy in high-risk head and neck cancer patients by administering Taxol postoperatively on weeks 2, 3, and 4 prior to RT. Taxol and Platinol were administered concomitantly with RT after week 4. This study was compared to the previous RTOG trial 9501, which administered Platinol alone with RT.
The current study enrolled 70 patients with high-risk head and neck carcinoma, which was defined as positive surgical margins, extracapsular nodal extension, or multiple positive lymph nodes. The median follow-up was 3.3 years. This regimen appeared to be reasonably well tolerated with a compliance rate of 75.4%. There was one death during the concurrent chemoradiotherapy part of treatment due to myocardial infarction.
The estimated two-year loco-regional relapse rate was 12.4%. New primary tumors occurred in 13.8%. The estimated two-year disease-free survival was 59.5%. The estimated two-year overall survival was 64.7%. A comparison to RTOG trial 9501 suggested an improvement in overall survival and disease-free survival. These authors suggest that this earlier treatment may represent an improvement over previous studies. They suggest that even earlier administration of chemotherapy postoperatively or prior to surgery (neoadjuvant administration) should be explored.
Comments: These data suggest that the addition of a taxane to high-risk patients treated with adjuvant Platinol and RT was of significant benefit.
1. Rosenthal DI, Harris J, Forastiere AA, et al. Early postoperative paclitaxel followed by concurrent paclitaxel and cisplatin with radiation therapy for patients with resected high-risk head and neck squamous cell carcinoma: Report of the Phase II Trial RTOG 0024. Journal of Clinical Oncology [early online publication]. August 31, 2009.