Full report of the TROG 03.01, NCIC CTG ES2 multinational phase III study in advanced esophageal cancer comparing palliation of dysphagia and quality of life in patients treated with radiotherapy or chemoradiotherapy.

Authors

null

Michael Gordon Penniment

Royal Adelaide Hospital, Adelaide, Australia

Organizations

Royal Adelaide Hospital, Adelaide, Australia

Research Funding

Other

Background: RT relieves dysphagia of advanced oesophageal cancer, without data from randomised phase III trials determining response, toxicity, or role of palliative CRT. Aims (1) to establish effective and least toxic treatment for symptom relief (2) determine effects of common cancer treatments on QoL (3) establish an evidence base for patient decision making. Methods: 220 patients were randomised to receive a course of palliative RT [35 Gy in 15 fractions, (n=115) or 30 Gy in 10 fractions (n=105) in Canada and UK], or concomitant CRT with Cisplatin and 5FU (D1-4) (n=111). Dysphagia measured using the Mellow score, toxicity using CTCAE v2, and QoL using EORTC QLQ30, oesophagus module (OES-18). The primary end point was proportion of patients with improved dysphagia measured at week 9 maintained until week 13. Results: Radiotherapy alone showed a dysphagia response (at any point) of 68% compared to CMT 74%, not a significant difference (p=0.343). the primary endpoint of maintained swallowing improvement was achieved in 41% with RT, 47% CMT again not statistically significant(p=0.4163).There was increased toxicity in patients receiving CRT, (nausea (p=0.0019) and vomiting (p=0.0072)). Median survival was 210 days for CRT, 203 days for RT. Although the results of the trial showed equally poor survival prognosis in both arms, there were some patients (n=21) still alive at 2 years post treatment.Quality of life analysis showed no statistical difference between arms. 17 patients in the RT alone arm ultimately received chemotherapy for specific palliative endpoints, thus 92 patients did not require chemotherapy. Conclusions: Although the CRT group had slightly better dysphagia response and median survival, the bowel toxicity was worse. Nearly 10% of patients were alive at 2 years indicating this is a group of patients who should not be denied active cancer treatment, but it should be tailored to offer maximum symptom relief minimising treatment toxicity. This multicentre trial, conducted in the UK, Canada, Australia, and New Zealand reflects practice in several countries. Clinical trial information: ACTRN12606000526572.

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Oral Abstract Session

Session Title

Oral Abstract Session: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

ACTRN12606000526572

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 6)

DOI

10.1200/jco.2015.33.3_suppl.6

Abstract #

6

Abstract Disclosures