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K. Cho
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MINI 07 - ChemoRT and Translational Science (ID 110)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:D. Raben, B. Kavanagh
- Coordinates: 9/07/2015, 16:45 - 18:15, 201+203
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MINI07.09 - Incorporating Erlotinib Into Chemoradiation Therapy for Unresectable Stage IIIA/B NSCLC: Interim Results of Ongoing Phase II Randomized Trial (ID 1761)
16:45 - 18:15 | Author(s): K. Cho
- Abstract
- Presentation
Background:
Combined chemoradiotherapy (CCRT) improves long-term outcome of patients (pts) with unresectable stage III non-small cell lung cancer (NSCLC). However, most pts die from distant failure due to preexisting occult metastases. Based on the premise that EGFR-TKI would improve the outcome of pts with stage III NSCLC that harbors sensitive EGFR mutations, as for the pts with stage IV NSCLC, we initiated a randomized phase II pilot trial that incorporated erlotinib (E) into CCRT treatment paradigms.
Methods:
Eligible pts over 18 years old with unresectable stage IIIA or IIIB NSCLC, ECOG PS 0–1, and adequate organ function were screened for EGFR mutation in axons 18–21 in the tumor sample. Those with EGFR mutation (+) tumors were randomized upfront to receive 3 cycles of 3-weekly E 150 mg/day treatment, and then either E x2 cycles concurrently with CCRT and x6 more cycles after CCRT (Arm A) or CCRT with 2 cycles of irinotecan-cisplatin (IP) but no additional therapy after CCRT (Arm B). When disease progression (PD) is documented during follow-up, E was re-instituted. Pts with EGFR mutation (-) or unknown tumors were randomized to receive either 3 cycles of IP induction followed by CCRT concurrently with 2 cycles of IP (Arm C) or CCRT with IP x2 first then consolidation with IP x3 (Arm D). IP chemo dose-schedule was irinotecan 60 mg/m[2] and cisplatin 30mg/m[2] iv on days 1 and 8 when given concurrently with RT (2.4 Gy/fx, total 60 Gy); irinotecan 65 mg/m[2] and cisplatin 30 mg/m[2] iv on days 1 and 8 when given every 3 weeks as induction or consolidation. The primary endpoint was overall response rate (ORR), toxicity, and overall survival (OS).
Results:
From 02/2008 to 03/2015, 59 pts (44 men and 8 women) with median age of 62 years (range: 37-78) were enrolled. There were 13 never smokers, 28 had adenocarcinoma, and 44 had IIIB tumors. EGFR mutation was (+) in 12, (-) in 28, and unknown in 19. There was apparent imbalance in histology and smoking status between the pts assigned to Arms A&B and C&D. ORR after induction E therapy was 75.0% for the 12 pts with EGFR mutation(+) tumors (Arm A, n=7; B, n=5). ORR after IP induction therapy was 63.6% for pts with EGFR mutation(-) or unknown tumors in Arm C (n=22). After completion of upfront CCRT therapy with IP in Arm D (n=25), ORR was 68.0%. There were no noticeable unusual side-effects. Median PFS for Arm A, B, C, and D, was 11.84, 8.09, 8.36, and 11.81 months respectively, with a trend toward better OS for pts with EGFR mutation(+) tumors (Arm A: not reached, B: 31.18 mos) than those EGFR mutation(-) or unknown tumors (Arm C: 17.93 mos, Arm D: 25.33 mos).
Conclusion:
The combined-modality treatment by molecular diagnostics is feasible in stage III NSCLC patients. Although the number is rather small, pts with EGFR mutation (+) tumors seem to be a distinct subset with better overall survival than the others, which warrants careful consideration in chemoradiation therapy trial design and outcome evaluation.
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P3.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 214)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Locoregional Disease – NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.03-023 - Phase III Study of Accelerated Hypofraction in CCRT of Unresectable Stage III NSCLC: Interim Analysis of KROG 0903 (ID 866)
09:30 - 17:00 | Author(s): K. Cho
- Abstract
Background:
KROG 0301 prospective phase I & II study of the modified hypofractionation using concomitant boost to the gross tumor volume (GTV) simultaneously in the patients with unresectable NSCLC showed outstanding results comparing to the previous ones. So, we designed phase III prospective clinical trial comparing it with the standard 2 Gy fractionation.
Methods:
Eligibility criteria were histologically proven unresectable stage III NSCLC determined by thoracic surgeon and more than one lesion measurable with CT scan according to the criteria of RECIST (version 1.1). Exclusion criteria were supraclavicular nodal metastasis, superior vena cava syndrome, atelectasia obscuring GTV contouring, and disease suspected to extend the major vessels and bronchus and to be at the risk of hemorrhage after concurrent chemoradiation (CCRT). In conventional fractionated RT group (Arm-1), a dose of 2Gy was delivered daily to the PTV and total cumulative dose was 44Gy to the PTV in 22 fractions and field was reduced and 2Gy was delivered to GTV and proceeded to 60Gy to the GTV in 30 fractions. In hypofractionated RT group (Arm-2), a dose of 1.8Gy was delivered daily to the PTV with a synchronous boost of 0.6Gy to the GTV to bring its daily dose to 2.4Gy per fraction. Total cumulative doses were 60Gy to the GTV and 45Gy to PTV in 25 fractions over 5 weeks. All patients received concurrent weekly chemotherapy consisting of paclitaxel first (50mg/m[2] intravenously over 1 hour) and cisplatin (20mg/m[2] intravenously over 1 hour) on days 1,8,15,22,29, and (36). Chemotherapy was performed before radiotherapy in a day. Dose modification of chemotherapy was guided according to the severity of toxicity.
Results:
One-hundred twelve patients who were followed more than 6 months after completion of planned treatment were included in this analysis. Median F-U was 14 months. Median age was 67 years(45-75) and male to female was 112/8. Stage IIIA was 81(72%) and IIIB 31(28%). Sixty and fifty-two patients were allocated in Arm-1 and 2, respectively. Patient’s characteristics were evenly distributed between two groups. Overall survival, local progression free, and disease progression free survival of all patients was median 30 months, 15months, and 12 months, respectively. Two- and 3-year survival rates were 53.6% vs. 54.1% and 50.4% vs. 44.6% in Arm-1 and Arm-2 (p=0.95), respectively. Two-year local tumor control rates were 58.3% and 50.0% (p=0.977) and 2-year progression free survival rates were 41.4% and 34.2% (p=0.704) in Arm-1 and Arm-2, respectively. Radiation esophagitis (≥ grade 2) was 15(25%) and 10(20%) and radiation pneumonitis (≥ grade 2) was 8(13.3%) and 7(13.5%) in Arm-1 and Arm-2, respectively.
Conclusion:
Interim analysis did not show any statistically significant toxicity or survival differences between two groups. This on-going clinical study needs to continue for the confirmative results.
