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T. Kozuka



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    P2.09 - Poster Session 2 - Combined Modality (ID 213)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P2.09-006 - Long-term results of a phase II trial of S-1 and cisplatin with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (ID 1371)

      09:30 - 09:30  |  Author(s): T. Kozuka

      • Abstract

      Background
      Concurrent chemoradiotherapy is the standard treatment for unresectable stage III non-small cell lung cancer (NSCLC). S-1 has been shown to be significant efficacious for treating advanced NSCLC. Our previous phase II study reported short-term outcomes of cisplatin (CDDP)/S-1 chemoradiotherapy. Because CDDP/S-1 chemoradiotherapy is considered to have advantages over others in overall survival (OS) and toxicity, we analyzed its long-term outcomes by following up patients included in the phase II study.

      Methods
      Forty-eight patients (aged <75 years) with unresectable stage III NSCLC were evaluated. They were treated with CDDP (60 mg/m[2] on day 1) intravenously and oral S-1 (40 mg/m[2] twice daily on days 1–14); this regimen was repeated every 4 weeks for four cycles. A 60-Gy thoracic radiation dose was delivered in 30 fractions beginning on day 2.

      Results
      After a median follow-up of 6.3 years (range, 5.7–7.4 years), the median OS was 2.8 years [95% confidence interval (CI); 1.04–4.63 years], and the 3- and 5-year OS rates were 49.7% (95% CI: 35.6%–63.8%) and 33.0% (95% CI: 20.0%–46.6%), respectively. Out of the several variables evaluated as predictors of OS, including gender, age, stage, histology, and performance status (PS), only PS proved to be a statistically significant predictor in both univariate and multivariate analyses.

      Conclusion
      CDDP/S-1 concurrent thoracic radiotherapy is clinically feasible and highly efficacious. Despite our relatively small sample size, the benefits of this regimen revealed in this study warrant further research.

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    P3.09 - Poster Session 3 - Combined Modality (ID 214)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P3.09-003 - Phase II study of nimotuzumab in combination with concurrent chemoradiotherapy (CRT) in patients with locally advanced non-small cell lung cancer (NSCLC). (ID 707)

      09:30 - 09:30  |  Author(s): T. Kozuka

      • Abstract

      Background
      Nimotuzumab, a humanized IgG~1~ monoclonal anti-EGFR antibody, is approved and widely used in patients (pts) with head and neck cancer or malignant glioma in combination with radiotherapy (RT) in several countries. In previous clinical studies, nimotuzumab has demonstrated a very mild and low incidence of skin toxicity compared to other anti-EGFR antibodies. On in-vitro and in-vivo experiments using NSCLC cell lines, nimotuzumab showed a radio-sensitizing effect.

      Methods
      This open-label, multicenter phase II study evaluated the tolerability and efficacy of nimotuzumab in combination with concurrent CRT in pts with unresectable locally advanced NSCLC. All eligible pts received concurrent thoracic RT (60 Gy, 2 Gy/day, 6 weeks from day 1) and 4 cycles of chemotherapy (cisplatin 80 mg/m[2] on day 1, vinorelbine 20 mg/m[2] on days 1 and 8) once every 4 weeks as scheduled. Nimotuzumab (200 mg) was administrated once a week from cycle 1 to 4. The primary endpoint was tolerability in combination with concurrent CRT, which was measured by the percentage of pts who completed 60 Gy of RT within 8 weeks, completed 2 cycles of chemotherapy and received more than 75% of nimotuzumab.

      Results
      Between June 2009 and May 2010, 40 pts were enrolled from 7 institutions in Japan, and 39 eligible pts received the study treatment. The pts characteristics (n = 39) were as follows: 62 years (median); male/female, 34/5; stage IIIA/B, 21/18; PS0/1, 25/14. Thirty-four pts (87%) met the criteria for treatment tolerability, and 38 pts (97%) completed 60 Gy of RT within 8 weeks. Infusion reaction, >grade 3 skin rash, >grade 3 radiation pneumonitis, or >grade 4 nonhematological toxicity were not observed. The 2-year overall survival rate for the 39 pts was 76% (95% CI; 59-87%). The median PFS was 16.7 months; and 30 pts were alive at the cutoff date (Nov 2011). The 1-year PFS rate for pts with squamous cell carcinoma (Sq; n = 16) was 75%, while that for pts with non-squamous cell carcinoma (non-Sq; n = 23) was 41%. In terms of the first relapse site, in-field relapse rates were low for both Sq (3/16; 19%) and non-Sq (3/23; 13%). However, the distant relapse rate was significantly higher for non-Sq (15/23; 65%) than that for Sq (2/16; 13%) (p<0.01, chi-square test with Yates correction).

      Conclusion
      Addition of nimotuzumab to the concurrent CRT in this setting was well tolerated with clinical benefit to the patients. The low in field relapse rates may be attributed to the radio-sensitizing effect of nimotuzumab. These findings warrant further clinical evaluation of nimotuzumab/cisplatin/vinorelbine/RT in a phase III trial.