A Phase I Trial of Outpatient Weekly Irinotecan/Carboplatin and Concurrent Radiation for Stage III Unresectable Non–Small-Cell Lung Cancer: A Vanderbilt-Ingram Cancer Center Affiliate Network Trial

Efficacy and Toxicity of Chemoradiotherapy with Carboplatin and Irinotecan Followed by Consolidation Docetaxel for Unresectable Stage III Non-small Cell Lung Cancer

“…The observed rate of radiation pneumonitis, including eight patients with grade more than or equal to 3 (26%), however, was unexpected compared with previous reports (Table 4). 5-7,10 -14,23-27 Grade more than or equal to 3 pneumonitis occurred in no more than 15% of patients in early Asian studies in which chemoradiotherapy with irinotecan was administered alone 10,11 or with carboplatin, 12,13 except in one study. Yamada et al 14 reported pneumonitis in 23% of patients treated with irinotecan (30 to 60 mg/m 2 weekly) and carboplatin (20 mg/m 2 for 5 days/wk).…”

“…For example, grading criteria and radiotherapy delivery in SWOG 0023 were similar to ours, but they waited longer after completing chemoradiotherapy before initiating docetaxel (4 -8 versus 3-4 weeks). Gaspar et al 37 recently 12 11/18 (61) NR NR Uejima et al 13 21/30 (72) Not reached Grade 2, 3/29 (10) Yamada et al 14 18/30 (60) 14.9 7/30 (23) Irinotecan and cisplatin Fukuda et al 23 40/48 (83) 21 5/48 (10) Langer et al 24 11/15 (73) 28 1/15 (7) Oka et al 25 16/23 (70) NR 0/23 (0) Takiguchi et al 26 6 reported that the incidence of grade more than or equal to 3 radiation pneumonitis was highly correlated with V 20 more than 35% (p Ͻ 0.01) in SWOG 0023 and was an independent factor in Cox regression analysis adjusted for other variables. This does not totally explain our findings as V 20 was 29% in our patients with radiation pneumonitis.…”

“…12 These early studies provided preliminary evidence of clinical activity, with objective response rates of 60 to 72%. [12][13][14] Based on the evidence available in 2003, when consolidation chemotherapy was a promising concept because of the results of the SWOG 9504 study, 5 we hypothesized that chemoradiotherapy with weekly carboplatin and irinotecan followed by consolidation docetaxel would be feasible and clinically active. To test this hypothesis, we conducted an open-label, investigator-initiated, single-arm phase II study of patients with unresectable stage III NSCLC.…”

“…Weekly irinotecan with concurrent radiotherapy was feasible in phase I studies, first as monotherapy 10,11 and, subsequently, in combination with carboplatin. [12][13][14] The dose-limiting toxicities of chemoradiotherapy with weekly irinotecan and carboplatin were nausea, vomiting, and esophagitis. 12 These early studies provided preliminary evidence of clinical activity, with objective response rates of 60 to 72%.…”

“…[12][13][14] The dose-limiting toxicities of chemoradiotherapy with weekly irinotecan and carboplatin were nausea, vomiting, and esophagitis. 12 These early studies provided preliminary evidence of clinical activity, with objective response rates of 60 to 72%. [12][13][14] Based on the evidence available in 2003, when consolidation chemotherapy was a promising concept because of the results of the SWOG 9504 study, 5 we hypothesized that chemoradiotherapy with weekly carboplatin and irinotecan followed by consolidation docetaxel would be feasible and clinically active.…”