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Y.Y. Chen



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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      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)

      11:05 - 11:10  |  Author(s): Y.Y. Chen

      • Abstract
      • Presentation
      • Slides

      Background
      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).

      Methods
      Patients with unresectable stage IIINSCLC were eligible. Patients received Endostar (7.5 mg/m[2]/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m[2]) and cisplatin (65 mg/m[2]) 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.

      Results
      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

      Conclusion
      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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    P1.13 - Poster Session 1 - SCLC (ID 200)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.13-008 - Omitting elective nodal irradiation and irradiating post-induction versus pre-induction chemotherapy tumor extent for limited-stage small cell lung cancer: an update of a prospective randomized trial (ID 3029)

      09:30 - 09:30  |  Author(s): Y.Y. Chen

      • Abstract

      Background
      Thoracic radiation target volume for limited-stage small cell lung cancer (SCLC) has long been a controversial topic. This study prospectively compares the local/regional failure pattern and overall survival (OS) between limited-stage SCLC patients who received different target volumes of thoracic radiotherapy (TRT) after induction chemotherapy.

      Methods
      Patients diagnosed as limited-stage (AJCC/UICC T1-4N0-3M0) SCLC received 2 cycles of etoposide and cisplatin (EP) and were randomly assigned to receive TRT to either the post-induction tumor extent (study arm) or pre-induction chemotherapy tumor extent (control arm). Elective nodal irradiation was omitted in both arms i.e. clinical target volume-nodal included only initially involved nodal regions. TRT dosage of forty-five Gy/30Fx/19d was administered concurrently with the third cycle of EP regimen. Then, additional 3 cycles of EP consolidation were administered. Prophylactic cranial irradiation was administered to patients who achieved complete or partial remission.

      Results
      Seventy-nine and 91 patients were randomly assigned to study arm and control arm. Five patients in study arm and 1 patient in control arm developed distant metastasis before TRT and received palliative treatment. One patient in study arm developed spontaneous pneumothorax and did not receive TRT. These patients were not included in the analysis of local/regional failure. However, they were included in the analysis of OS. Median follow up time for the whole group was 15.6 months (1.1 months- 129.3 months). The local recurrence rates were 30.1% (22/73) and 33.3% (30/90) respectively (P = .73). The isolated nodal failure (INF) rates were 2.7% (2/73) and 5.6% (5/90) respectively (P = .46). All INF were developed in supraclavicular regions except for one patient developed contralateral hilum lymph node recurrence. The estimated 1 and 2-year local/regional progression free survival time were 88.6%, 82.1% and 77.3%, 63.5% respectively in study arm and control arm (P = .56). The median OS time were 23.5 months (95% CI: 15.5-31.4 months) and 25.4 months (95% CI: 19.6-31.1 months) respectively in study arm and control arm. One, three and 5-year OS rates were 79.4%, 33.6%, 22.5% and 84.0%, 34.3%, 29.1% respectively (P = .74).Figure 1

      Conclusion
      The results indicate that irradiation to the post-chemotherapy tumor extent and initially involved positive nodal regions did not increase local/regional failure. However, the sample number in this analysis did not meet the design requirements. Enrollment of patients is still in progress.