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Nonsurgical Treatment of Non–Small Cell <strong>Lung</strong> <strong>Cancer</strong> 149<br />

Table 8–4. Schema for Radiation Therapy Oncology Group Trial 88–08:<br />

Effect of Chemotherapy on Failure Patterns in Patients with<br />

Unresectable NSCLC Treated with Radiation Therapy<br />

Stratification criteria<br />

Histology: squamous vs other<br />

Karnofsky performance status: 70–80 vs 90–100<br />

Stage: II vs IIIA vs IIIB<br />

Arm 1 (conventional radiation therapy)<br />

60 Gy in daily 2.0-Gy fractions over 6 weeks<br />

Arm 2 (chemotherapy followed by conventional radiation therapy)<br />

Vinblastine weekly for 6 weeks<br />

Cisplatin on days 1 and 29<br />

Conventional radiation therapy beginning on day 50<br />

Arm 3 (hyperfractionated radiation therapy)<br />

69.6 Gy in twice-daily 1.2-Gy fractions over 6 weeks<br />

were randomly assigned to treatment with conventional radiation therapy<br />

alone, hyperfractionated radiation therapy alone, or chemotherapy<br />

followed by conventional radiation therapy. Treatment details are given<br />

in Table 8– 4. The median survival in the group that received chemotherapy<br />

was 13.8 months, compared to 11.4 months among the patients who<br />

received hyperfractionated radiation therapy. The 2-year survival rate<br />

was 32% among the patients who received combined treatment versus<br />

19% among the patients who received hyperfractionated radiation therapy<br />

(P .003).<br />

RTOG trial 91–06 was a phase II trial in which patients received a combination<br />

of the most effective radiation therapy regimen identified in RTOG<br />

trial 83–11 (a total dose of 69.6 Gy) and concurrent oral etoposide and intravenous<br />

cisplatin (Lee et al, 1996). Eligibility criteria included unresectable<br />

NSCLC, good performance status, and weight loss less than 5%. Among the<br />

76 patients enrolled, the 2-year survival rate was 40%, and the median survival<br />

was 19.7 months (Lee et al, 1996). This median survival was better<br />

than the median survival of 10.3 months in RTOG trial 83–11 (twice-daily<br />

radiation therapy alone) (Table 8–5) (Komaki et al, 1997b). However, acute<br />

esophagitis was significantly more common among the patients treated<br />

with twice-daily radiation therapy and concurrent chemotherapy.<br />

At M.D. Anderson, RTOG trial 92–04 was activated in 1992 to compare 2<br />

combinations of chemotherapy and radiation therapy in patients with inoperable<br />

stage II or III NSCLC, a Karnofsky performance status score of 70 or<br />

higher, and minimal weight loss (Komaki et al, 1997a, in press). Treatment<br />

details are given in Table 8–6. The arm-1 treatment (induction chemotherapy<br />

followed by concurrent chemoradiation) was based on previous RTOG

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