Author of

• 11673

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

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Combined Modality
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11681

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    P2.09-008 - Concurrent chemoradiotherapy (cCTRT) for locally advanced Non Small Cell Lung Cancer (NSCLC) followed by consolidation Pemetrexed: a phase II study (ID 1545)

    09:30 - 09:30  |  Author(s): C. Scharf
    • Abstract

    Background
    cCTRT is the current standard treatment for good Performance Status (PS) unresectable locally advanced NSCLC. A phase III study demonstrated that Docetaxel consolidation does not improve overall survival (OS) after cCTRT (Hanna. JCO 2008). The role of consolidation chemotherapy after cCTRT is still investigational and our study was set up to evaluate the role of pemetrexed in this setting. A less toxic consolidation chemotherapy may enable a higher proportion of patients to comply to planned treatment which may improve outcome.

    Methods
    This was a single-institution prospective phase II study. Treatment comprised cisplatin (50 mg/m[2] days 1, 8, 29, 36), etoposide (50 mg/m[2] days 1-5 and 29-33) and concurrent thoracic radiotherapy starting on day 1 chemotherapy (66 Gy in 33 daily fractions; 3D conformal radiotherapy or IMRT) followed by consolidation pemetrexed (500 mg/m[2] on days 71, 92 and 133). The primary endpoint was 1 year OS. Secondary endpoints were progression-free survival (PFS), 2 yr OS, acute/late toxicity (CTCAE v3.0), compliance to treatment.

    Results
    35 patients were recruited between March 2008 and October 2010. Median age was 61 years (range 42-76). M:F ratio was 23(66%):12(34%). ECOG PS was 0:1 11(31%):24(69%). Histology: squamous 21(60%), adenocarcinoma 8(23%), undifferentiated 4(11%), other 2(6%). Stage: IIB 1(3%), IIIA 19(54%), IIIB 15(43%). All 35(100%) had PETCT staging. All 35 patients received concurrent chemotherapy (dose reduction in 3 patients) and 32 (91%) received the planned 66Gy (range 56-66 Gy). The number of patients who completed pemetrexed were: cycle 1=25 (71%), cycle 2=22 (63%), cycle 3=16 (46%). Radiation parameters: Gross Tumour Volume (GTV) was median 60.2 cm[3] (range 11.4-274.4 cm[3]), V~20Gy ~median 30.4% (range 10.5-35.3%), During the concurrent phase, grade 3/4 toxicity was noted for: neutropenia 17(49%) anaemia 1(3%), thrombocytopenia 1(3%), infection 8(23%), fatigue 6(17%), nausea±vomiting 4(11%), mucositis 3(9%), anorexia 3(9%). During the pemetrexed consolidation phase, the only grade 3/4 toxicities were: infection 5(20%), anaemia 3(12%), neutropenia 2(8%) and fatigue 2(8%). Acute radiotherapy toxicity (<3months): oesophagitis grade 3/4 10(29%) and late toxicity (>3months): pneumonitis grade 3/4 2(7%), oesophageal stricture 2 (7%), pulmonary fibrosis 1(3%). Median follow up was 25months. Median OS was 34months, with 1yr OS 77% (95% CI 60-88%), and 2yr OS 61% (95% CI 37-72%). Median PFS was 22months, with 1yr PFS 62% (95% CI 43-76%) and 2yr 49% (95% CI 31-65%). Of the 14 deaths, causes were, 1 suicide during radiotherapy, 2 treatment-related deaths (1 grade 5 pneumonitis and 1 grade 5 haemoptysis) and 13 due to lung cancer.

    Conclusion
    In an unselected locally advanced NSCLC population, staged with PETCT a median survival of 34 months can be achieved. The study reinforces the challenge of delivering consolidation chemotherapy and suggests that improved staging contributes to improved outcomes. Although there was failure to deliver all planned cycles of consolidation pemetrexed after cCTRT in 54% of patients, these are encouraging results that warrant further investigation.