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C. Lewanski

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    MO07 - NSCLC - Targeted Therapies II (ID 114)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO07.11 - A randomised placebo-controlled multicentre phase II trial of erlotinib plus whole brain radiotherapy for patients with advanced non-small cell lung cancer with multiple brain metastases (TACTIC) (ID 2305)

      16:15 - 17:45  |  Author(s): C. Lewanski

      • Abstract
      • Presentation
      • Slides

      Median survival of non-small cell lung cancer (NSCLC) patients with brain metastases is poor. We examined concurrent erlotinib and whole brain radiotherapy (WBRT) followed by maintenance erlotinib in patients with untreated brain metastases, given the potential radiosensitising properties of erlotinib and its direct effect on brain metastases and systemic activity.

      Eighty NSCLC patients with KPS≥70 and multiple brain metastasis were randomised to placebo (n=40) or erlotinib (100mg, n=40) given concurrently with WBRT (20 Gy in 5 fractions). Following WBRT, patients continued with placebo or erlotinib (150mg) until disease progression. The primary end-point was neurological progression-free survival (nPFS).

      Fifteen patients (37.5%) from each arm were alive and without neurological progression 2 months after WBRT. Median nPFS was 1.6 months in both arms; nPFS HR 0.95 (95% CI, 0.59-1.54; p=0.84). Median overall survival (OS) was 2.9 and 3.4 months in the placebo and erlotinib arms; HR 0.95 (95% CI, 0.58-1.55; p =0.83). The frequency of EGFR mutations was low with only 1 out of 35 (3%) patients with available samples had activating EGFR-mutations. Grade 3/4 adverse event rates were similar between the two groups (70% in each arm), except for rash 20% (erlotinib) vs. 5% (placebo), and fatigue 17% vs. 35%. No significant QoL differences were found.

      Our study showed no advantage in nPFS or OS for concurrent erlotinib and WBRT followed by maintenance erlotinib in patients with predominantly EGFR wild-type NSCLC and multiple brain metastases. Future studies should focus on the role of erlotinib with or without WBRT in patients with EGFR mutations.

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    P1.09 - Poster Session 1 - Combined Modality (ID 212)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P1.09-009 - Preliminary Safety and Treatment Delivery Data During Concurrent Phase of Chemoradiation Therapy of the PROCLAIM Trial: A Phase 3 Trial of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Stage III Nonsquamous Cell Lung Cancer. (ID 1196)

      09:30 - 16:30  |  Author(s): C. Lewanski

      • Abstract

      Pemetrexed platinum regimens, unlike other regimens, can be given at full systemic doses with thoracic radiation therapy (TRT) in locally advanced stage III nonsquamous non–small cell lung cancer (NSCLC). Study JMIG was initiated to determine if this finding would translate into a survival advantage versus contemporary standard of care.

      Study JMIG randomized patients with stage III unresectable nonsquamous NSCLC to experimental Pem+Cis (pemetrexed plus cisplatin and concurrent TRT for three 21-day cycles, followed by consolidation pemetrexed) or to control Etop+Cis (etoposide plus cisplatin and concurrent TRT for two 28-day cycles, followed by consolidation chemotherapy regimen of choice [excluding pemetrexed]). The primary objective was overall survival of Pem+Cis compared with Etop+Cis with safety as a secondary objective using Common Terminology Criteria for Adverse Events (CTCAE). Adverse event incidences were analyzed using Fisher’s exact test (2-sided α=0.05).

      Of 598 randomized patients, 555 received treatment: 283 Pem+Cis and 272 Etop+Cis. Baseline characteristics were similar (Pem+Cis/Etop+Cis); age (mean±SD) 59.2±9.5/58.7±9.3 years; women, n=114 (40.3%) / n=105 (38.6%); stage IIIB, n=153 (54.1%)/n=138 (50.7%); Eastern Cooperative Oncology Group performance standard of 1, n=138 (48.8%)/n=137 (50.4%); and planned target volume (mean±SD) 628.9 ±463.3/581.2±417.0 ml. Pem+Cis mean weekly dose intensities were 95.9% for both pemetrexed and cisplatin; Etop+Cis dose intensities were 96.4% and 94.1% for etoposide and cisplatin. TRT therapies were similar (Pem+Cis/Etop+Cis); TRT median (range) of 66.0 (2.0–66.3) gray (Gy)/66.0 (2.0–66.0) Gy, mean (SD) number of fractions 31.4 (4.3)/31.1 (5.2), V20 of 27.5% (6.5%)/26.7% (7.3%). Table 1 summarizes AEs during the concurrent phase by treatment. Few patients (n≤4) had grade 3 or 4 CTCAE of mucositis/stomatitis or rash. Pem+Cis had fewer SAEs of febrile neutropenia and pneumonia but increased vomiting compared with Etop+Cis. Nine patients died during the concurrent phase (not included in this safety analysis by treatment to preserve the integrity of final efficacy analysis).

      Table 1. Summary of Common Terminology Criteria for Adverse Events Grade 3 Plus 4 Occurring in ≥2% of Patients Randomized and Treated
      CTCAE (Grades 3 and 4) Pem+Cis N=283 n (%) Etop+Cis N=272 n (%) p-value
      Patients with ≥1 CTCAE* 170 (60.1) 186 (68.4) 0.042
      Neutrophils/granulocytes* 52 (18.4) 78 (28.7) 0.005
      Leukocytes* 44 (15.5) 65 (23.9) 0.014
      Esophagitis 42 (14.8) 47 (17.3) 0.488
      Lymphopenia 48 (17.0) 37 (13.6) 0.290
      Hemoglobin 14 (4.9) 20 (7.4) 0.289
      Febrile neutropenia 9 (3.2) 18 (6.6) 0.075
      Dysphagia 18 (6.4) 16 (5.9) 0.861
      Platelets 15 (5.3) 16 (5.9) 0.854
      Vomiting 12 (4.2) 13 (4.8) 0.839
      Hypokalemia 6 (2.1) 12 (4.4) 0.153
      Infection—lung (pneumonia)*[a] 1 (0.4) 9 (3.3) 0.010
      Dehydration 11 (3.9) 8 (2.9) 0.643
      Nausea 13 (4.6) 8 (2.9) 0.376
      Anorexia 10 (3.5) 7 (2.6) 0.625
      Fatigue 9 (3.2) 6 (2.2) 0.603
      Hyponatremia 5 (1.8) 6 (2.2) 0.768
      Thrombosis/thrombus/embolism 7 (2.5) 5 (1.8) 0.772
      Abbreviations: Cis = cisplatin; CTCAE = Common Terminology Criteria for Adverse Events, Version 3.0; Etop = etoposide; N = number of patients dosed; n = number of patients with at least one CTCAE; Pem = pemetrexed.
      * Statistically significant; p<.05 based on Fisher’s exact test.
      [a] CTCAE was defined as Infection (clinical/microbio)—Gr3/4 neutrophils—Pulmonary/upper respiratory—Lung (pneumonia).

      During the concurrent treatment phase, patients with stage III locally advanced nonsquamous NSCLC in either treatment arm received comparable systemic therapy; however Pem+Cis had significantly lower incidences of some toxicities. Further toxicity differences may emerge with longer follow-up.