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Surgery plus adjuvant radiotherapy had long been the standard treatment for patients with squamous cell carcinoma of the head and neck.
Analyses of other disease sites 2,3 had suggested that adding chemotherapy to adjuvant radiation treatment could be beneficial, especially in the high risk group.
To be eligible for the study, patients had a diagnosis of squamous cell carcinoma of the head and neck arising from any of the following sites: oral cavity, oropharynx, larynx, or hypopharynx.
The authors of the RTOG 9501 paper thus concluded that post-operative concurrent Cisplatin-based chemotherapy and radiotherapy improves locoregional control of squamous cell carcinoma of the head and neck, as well as disease free survival. Though RTOG 9501 was a randomized trial, the patients were initially stratified prior to randomization on the basis of age and margin status. Objective definitions were employed to measure outcomes: Disease-free survival was measured from the time of randomization to the time of discovery of the first evidence after treatment of any tumor (local, regional, metastatic, or second primary) or death from any cause. RTOG 9501 was run concurrently with European Organization for Research and Treatment of Cancer (EORTC) trial 22931, which also investigated concurrent adjuvant chemotherapy and radiation therapy in high risk SCC of the head and neck. Bernier et al then performed a subgroup analysis of the patients who overlapped in the eligibility criteria for both trials, i.e. This entry was posted in all, Journal Commentaries, Medical Professionals and tagged Head and neck cancer, Jonathan Klein, New England Journal of Medicine, Radiation therapy, Squamous cell carcinoma.
They had to have undergone a surgical resection with no gross disease remaining and have at least one high risk characteristic, namely: ?2 nodes involved, extracapsular extension (ECE) of nodal disease, or involved surgical margins. However, this benefit comes at the risk of increased acute toxicities, such as mucositis, pharyngitis, esophagitis, and acute skin reactions. The trial was also not fully blinded, as patients would know whether they were receiving chemotherapy or not.

Overall survival was measured from the date of randomization to the date of death from any cause. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. Cornwall on Hospital, Hospice or Home: Choosing Where Your Child DiesTom caton on The Gift of CancerHalina Witt on Glenn Sabin Series, Part One: Do not just Watch and Wait!
They also needed to be clinically able to tolerate chemotherapy with Karnofsky Performance Status4 ? 60 (see Figure 1), WBC ? 3.5, platelet count ? 100m and a creatinine clearance ? 50.
The designers assumed a 10% attrition rate among patients in the study, and so required 438 patients to proceed with the study. Though not statistically significant, there was a trend towards an overall survival advantage as well. The authors designed an appropriate randomized controlled trial to investigate the question and test their hypothesis. However, aside from employing some form of “sham chemotherapy,” blinding is not possible for this type of treatment.
Jay Cooper, the leader of RTOG 9501, et al published a review of the two studies combined in the journal Head and Neck in 2005.7 They concluded that differences in patient characteristics between the two trials were likely related to the difference in overall survival. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC).

In the end 459 patients were recruited, 43 were declared ineligible, and 201 entered the control arm and 206 entered the treatment arm. The authors posit, though, that because of relatively short follow-up times, the effect may have been obscured.
The conclusions were justified by the results of the study within patients who fit the inclusion criteria for the study.
For example, RTOG 9501 had 94% of patients with N2 or N3 disease while EORTC 22931 had 57%; EORTC 22931 also had more hypopharyngeal carcinoma (20% vs. The subgroups that had neither of these characteristics showed no survival benefit in either trial.
Had the study followed patients for longer, perhaps, the divergence of the overall survival curves could have become statistically significant.
The treatment portals could not cover all high-risk disease in 8 percent of patients in the control arm and in 10 percent in the treatment arm. EORTC 22931 agreed with RTOG 9501 in that locoregional control and disease-free survival are significantly improved by the addition of chemotherapy.
As a result, Bernier proposed that Cisplatin-based chemotherapy should be added to post-operative radiotherapy for patients with one or both of these characteristics.
The dose, number of fractions, or total time was unacceptable in 6 percent of control arm patients and 5 percent of treatment arm patients did not receive the specified dose, number of fractions, or total treatment time.

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