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Patient-reported Outcomes Offer Noteworthy Insight to Quality of Life for Patients with NSCLC

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Based on research presented at the American Society for Radiation Oncology's (ASTRO's) 55th Annual Meeting, an analysis of quality of life (QOL) data of stage III lung cancer patients who were given higher doses of radiation therapy (alongside chemotherapy) illustrates a considerably lower quality of life at 3 months following treatment as opposed to patients who were given a standard dose of radiation (alongside chemotherapy).

The study also points out that lung cancer patients who were administered intensity modulated radiation therapy (IMRT) reported less decline in their QOL as opposed to those receiving three-dimensional conformal radiation therapy (3-D CRT).

Patient data was amassed from the RTOG 0617 study, a phase III, randomized clinical trial of patients with locally advanced non-small cell lung cancer (NSCLC) carried out from 2007 to 2011. The randomized study compared a high-dose (HD) of 74 Gy to a standard dose (SD) of 60 Gy. All registered patients were administered simultaneous chemotherapy of carboplatin/paclitaxel, in addition of being randomized to be treated with or without cetuximab (C225).

The radiation was carried out with two kinds of radiation therapy (RT): 3-D CRT, in which beams of radiation are shaped to match the tumor, or IMRT, a more sophisticated method that uses a computer-controlled algorithm to adjust the intensity of each beam to further spare normal tissue. While the study was not randomized for the radiation treatment technique (3-D CRT or IMRT), the pretreatment characteristics were not entirely different for these methods except that higher stage tumors were treated with IMRT.

Preceding results of a planned analysis of the trial saw that the higher dose of radiation therapy was linked with lower overall survival (OS), at which point, the high-dose radiation therapy arms of the study were discontinued. 

And since the RTOG study specified that OS rates were lower with higher doses of radiation, despite a few differences in provider-reported toxicity between the study's arms, researchers assessed if patient-reported outcomes had any impact on the results for the RTOG 0617 trial. 

Patient QOL scores were compared between the treatment arms, as well as between the RT methods. QOL information was gathered using the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI), which is an anthology of physical well being (PWB), functional well being (FWB), and lung cancer subscale (LCS) results. Results were examined at baseline, at the cessation of chemoradiation, and at three months and 12 months following treatment. Two-sample t-tests, the Wilcoxon-Mann-Whitney test and the Chi-Square test compared QOL between arms and between technologies (3-D CRT vs. IMRT) using two-sided p values and effect sizes (ES).

Baseline FACT-TOI were concluded from each arm on 88 percent of patients, with no difference in patient demographics, baseline QOL scores or C225 use. Seventy-one percent of patients completed QOL data at three months, of whom around 60 percent of patients (225) completed it at 12 months.

The main QOL estimation was that there would be a considerable difference between arms at 3 months using the LCS, which centers on key symptoms of lung cancer. A clinically meaningful decline (CMD) in LCS for patients receiving 74 Gy was considerably higher at three months following treatment (46 percent) than for patients receiving 60 Gy (31 percent, p=0.024, ES 0.4); however, these differences resolved by 12 months, with the 74 Gy dose producing a CMD of 36 percent, and the 60 Gy dose producing a CMD of 39 percent (p=0.7, ES<0.1).

Furthermore, the results point out that IMRT, which was given to 45 percent of patients in each arm, was connected to a significantly lower decline in QOL as opposed to those who received 3-D CRT, even a year following treatment. In fact, at 12 months post-treatment, 23 percent of the IMRT patients in either arm had a CMD in LCS, compared to 47 percent of 3-D CRT patients (p=0.005, ES 0.3).

"This study further emphasizes the critical importance of patient-reported outcomes. The fact that the QOL scores were initially lower in the high-dose radiation arm was illuminating because few differences in toxicity between the arms were noted by the health care providers. Thus, the patient-reported outcomes help tell 'the rest of the story.' Another intriguing discovery with our analysis was that QOL was significantly improved with the use of more sophisticated technology, i.e. IMRT (relative to 3-D CRT), suggesting that advanced radiation treatment techniques may provide meaningful QOL benefits for patients with non-small cell lung cancer,” said lead author of the study and chairman of the department of radiation oncology at the Henry Ford Health System in Detroit, Benjamin Movsas, MD.

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