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J.Y. Song
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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 - 09:30 | Author(s): J.Y. Song
- 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.
