Definitive results of a comparative longitudinal quality of life study using the Spitzer index in the randomized multicentric phase III trial FFCD 9102 (surgery vs. radiochemotherapy in patients with locally advanced esophageal cancer)
Reviewer: S. Jack Wei, MD
Last Modified: June 2, 2003
Presenter: F Bonnetain
Presenter's Affiliation: Federation Francophone de Cancerologie Digestive
Type of Session: Scientific
FFCD 9102 was a randomized trial comparing chemoradiation + surgery versus chemoRT alone for locally advanced, but resectable esophageal cancer. The results were previously presented and showed no difference in overall survival between the two groups. Quality of life (QoL)after treatment is important in directing treatment. It is particularly important when no survival difference is seen. This study addresses the QoL of patients treated in FFCD 9102.
Materials and Methods
- Patients were eligible for FFCD 9102 if they had T3N0-1, resectable cancer of the esophagus.
- 259 patients were randomized to induction RT + 5-FU/cisplatin chemotherapy followed by either continuation of chemoRT or surgery.
- QoL was measure using the Spitzer index, a quality of life assessment tool based on assessment by the clinician.
- QoL scores were measured at baseline prior to any treatment, immediately after completion of treatment, and in followup: every 3 months for two years, then every 6 months thereafter.
- As was previously reported, there was no difference in OS between the 2 groups (p=0.56).
- More patients in the chemoRT group than the surgery group underwent palliative procedures for dysphagia including stent placement and esophageal dilation (46% vs. 24%).
- At baseline, there no difference between the 2 arms with regards to the Spitzer Index score.
- At first follow-up, Spitzer Index score was higher for the chemoRT group (p=0.009)
- Longitudinal assessment of QoL showed that this difference was no longer present on further follow-up (p=0.26).
- Longitudinal QoL did not differ between the two treatment groups.
- QoL immediately following treatment appeared to be better for patients undergoing definitive chemoRT.
- This improved early QoL was seen despite a higher rate of palliative procedures for dysphagia needed in the chemoRT group.
The results of this study indicate that there may be a small, early advantage in QoL for definitive chemoRT over surgery; however, this benefit did not remain on further follow-up. The QoL index used is based on clinician assessment and may not be an accurate reflection of QoL as perceived by the patient. Given the lack of OS difference between the two treatment arms and the lack of a definitive difference in QoL, the optimal treatment for locally advanced but resectable esophageal cancer remains unclear.
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