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MO25 - NSCLC - Combined Modality Therapy II (ID 112)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Mesothelioma
- Presentations: 1
- Moderators:T. Le Chevalier, K. Pittman
- Coordinates: 10/30/2013, 10:30 - 12:00, Parkside Ballroom B, Level 1
MO25.06 - Phase I/II trial of recombinant human endostatin in combination with concurrent chemo-radiotherapy in the patients with stage III non-small-cell lung cancer (ID 2325)
10:30 - 12:00 | Author(s): J. Wang
Endostatin has been proved to be a potent endogenous angiogenic inhibitor. Recombinant human endostatin (Endostar) was reported to be efficient in blocking angiogenesis and suppressing tumor growth. Preclinical studies demonstrated that Endostar could normalize tumor vasculature, alleviate hypoxia and sensitize the function of radiation. This study was conducted to evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with stage IIInon-small-cell lung cancer (NSCLC).
Patients with unresectable stage IIINSCLC were eligible. Patients received Endostar (7.5 mg/m/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m) and cisplatin (65 mg/m) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy. Primary end points included the short-term efficacy and treatment-related toxicity of Endostar combined with CCRT.
In all, 50 patients were enrolled onto the study, and 48 were assessable. Median follow-up was 32.1 months. Response rate was 77%. The estimated median progression-free survival (PFS) was 10.2 months and the estimated median overall survival (OS) was 22.6 months. The 1-year and 2-year PFS rates were 48% and 25%, respectively. The 1-year and 2-year OS rates were 81% and 47%, respectively (Figure 1).Nine patients (19%) experienced grade 3 or higher treatment-related nonhematologic adverse events (AEs). Predominant nonhematologic toxicities were grade 3 esophagitis (n = 4; 8%), and grade 3 to 5 pneumonitis (n = 6; 13%). The rates of observed grade 3 and 4 hematologic AEs were 77% (n = 37). The predominant hematologic toxicity was grade 3 to 4 lymphopenia (n = 32; 67%) and neutropenia (n = 23; 48%). Overall, the entire treatment regimen was well tolerated. Figure 1 Figure 1
The combination of Endostar with CCRT is feasible and shows promising activity. This regimen should be studied further in patients with locally advanced NSCLC.
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P2.08 - Poster Session 2 - Radiotherapy (ID 198)
- Event: WCLC 2013
- Type: Poster Session
- Track: Radiation Oncology + Radiotherapy
- Presentations: 1
- Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
P2.08-003 - Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study (ID 311)
09:30 - 16:30 | Author(s): J. Wang
Whether IFRT could replace ENI or not has been a controversial topic for years because of rare data from large sample sizes, prospective, randomized studies were available. This study is to evaluate the locoregional failure and its impact on survival by prospectively comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) for locally advanced non-small cell lung cancer with concurrent chemoradiotherapy.
Patients were randomized into IFRT or ENI arm，treated with 2 cycles of carboplatin combined with paclitaxel. Those without distant metastasis continued to receive chemoradiotherapy. The target volumes for IFRT included primary tumor, ipsilateral hilum and positive mediastinal lymph nodes, while that for ENI included the primary lesion, ipsilateral hilum, bilateral mediastinal lymph node drainage areas and bilateral supraclavicular fossa. The radiation dose was prescribed as high as possible if the restrictions could be met: percent volume of bilateral lung receiving ≥ 20Gy (V20) was ≤35% and the maximum dose to spinal cord was ≤50Gy.
99 consecutive patients were assigned (45 IFRT vs. 54 ENI), with more patients in IFRT iiradiated with ＞60Gy than those in ENI (48.9% vs. 25.9%, P=0.018). the local failure rates were 34.1% and 30.0%（P=0.673）, Of which the isolated ENF was 0.0% and 2.0%, respectively (P=0.363). The median survival time was 27.8 months (95% CI, 18.0-37.5 months) and 16.7 months (95% CI, 15.0-18.4 months); the 1-, 2- and 3-year local tumor progression-free survival rates were 78.1%、72.6%、62.9% and 85.5%、61.2%、56.1% （P=0.895）, respectively; the 1-, 2- and 3-year overall survival rates were 80.0%、53.3%、36.6% and 70.4%、34.9%、30.3% （P=0.08）, respectively.
Preliminary results indicated that IFRT did not increase locoregional failure related to ENF. With IFRT, higher radiation dose could be administered compared with ENI and it is expected to improve survival. Further investigation is warranted.