One Year Follow-up Reveals No Difference in Quality of Life Between High Dose and Conventional Dose Radiation: A Quality of Life Assessment of RTOG 94-05

Ryan Smith, MD
University of Pennsylvania Cancer Center
Last Modified: November 6, 2001

Presenter: L.A. Kachnic
Presenter's Affiliation: Radiation Therapy Oncology Group
Type of Session: Scientific

Background

Nonsurgical standard of care for esophageal cancer is concurrent chemoradiation. A survival advantage has been demonstrated using chemoradiation to a dose of 50.4 Gy over radiation alone.

Many believe that dose escalation would yield higher response rates and survival, though at a cost of higher toxicity.

This is a study of quality of life of an RTOG study that compared high dose chemoradiation (64.8 Gy) to conventional chemoradiation (50.4 Gy).

Materials and Methods

RTOG 94-05 was a prospective randomized trial of 236 patients with T1-4NxM0 esophageal cancer randomized to standard dose or high dose chemoradiation.

Conventional Dose Arm (CD): 50.4 Gy/1.8 Gy fractions with concurrent 5-FU and cisplatin on weeks 1 and 5. Repeated 4 weeks post radiation.

High dose Arm (HD): 64.8 Gy /1.8 Gy fractions with the same chemotherapy as above

169 patients participated in the quality of life (QOL) assessment with pretreatment characteristics balanced in both arms.

QOL was assessed using the Functional Assessment of Cancer Therapy, Head and Neck (version 2)

This was a self assessment using 5 subscales: physical well being, social/family well being, relationship with their physician, functional well being, and emotional well being

Assessment was done pre-treatment, post-treatment, 8 months after the initiation of treatment, and 1 year after the initiation of treatment, then every 6 months until year 5.

Results

3 year analysis of RTOG yielded no difference in survival. The reason for this negative result was the number of treatment deaths, which occurred in 11 (11%) of those in the high dose arm vs 2 (2%) in the conventional arm. However, all deaths occurred prior to 50.4 Gy.

Pre-treatment analysis: Patients were most concerned about pulmonary status. Females had a decreased QOL compared to males, which was more pronounced in the HD arm. Pre-treatment weight loss and squamous cell histology were also correlated with decreased QOL.

Post-treatment analysis: 96 patients (57%) participated. QOL was worse (when compared to pre-treatment assessment) in both arms, with a significant decrease in the HD arm. Again, female gender and weight loss correlated with lower QOL scores.

8 month post-treatment analysis: 73 patients (43%) participated (most common reason for dropout was patient death). QOL returned to baseline, while head and neck concerns improved to better than baseline in both groups. There was no difference between the HD and CD arms. There was no significant effect of gender on QOL scores.

1 year post-treatment analysis: 57 patients (34%) participated. Again, there was no difference in QOL between the two arms.

Author's Conclusions

Female gender and weight loss correlated with worse pre-treatment QOL

QOL scores decreased in both groups after treatment when compared to pre-treatment. Total QOL scores were significantly worse in the HD arm.

By 8 months, these QOL scores returned to baseline, but only improved in areas of head and neck concerns. There was no difference in QOL at 8 months or 1 year between the two groups.

Clinical/Scientific Implications
Control of esophageal cancer is poor. The best nonsurgical results have been seen with concurrent chemoradiation to a dose of 50.4 Gy. However, many believe dose escalation to >50.4 Gy would result in better tumor control and survival, however, there is a question as to whether this can be safely done. This study indicates, as expected, that QOL scores decrease after treatment, almost certainly due to acute toxicity of treatment. Again, as expected, this was significantly worse in the HD arm. QOL scores were improved by 8 months, with the conclusion that, although acute toxicity is worse with higher doses of radiation, after these acute toxicities resolve, QOL is equal in both groups. This is encouraging, but unfortunately, 1 year out of treatment is too early to gauge chronic (long term) effects. This is a large concern with higher doses, especially when concurrent with chemotherapy. This could be especially enhanced in this group of patients, since cisplatin is such a radiosensitizing agent. Therefore, these results should be taken with some caution.

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