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B. Biesma



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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): B. Biesma

      • Abstract

      Background
      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.

      Methods
      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).

      Results
      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).

      Conclusion
      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.

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    P3.13 - Poster Session 3 - SCLC (ID 202)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.13-006 - Docetaxel-Carboplatin (DC) as Second Line Treatment in Patients With Small Cell Lung Cancer (SCLC): A phase II study. (ID 1877)

      09:30 - 16:30  |  Author(s): B. Biesma

      • Abstract

      Background
      Patients with relapsing SCLC have a poor prognosis and options for treatment are limited. Paclitaxel in combination with platinum has demonstrated activity in first and second-line treatment. We conducted a phase II study to investigate the anti-tumor activity and safety profile of Docetaxel/Carboplatin (DC) in patients with refractory or relapsing SCLC.

      Methods
      SCLC patients who were refractory to or relapsed after first-line treatment and who did not receive platinum based chemotherapy within the 3 months before inclusion, were treated with Docetaxel (75 mg/m[2], day 1 iv) followed by Carboplatin (area under the curve 6, day 1 iv.) once every 3 weeks for 4-6 cycles. Primary endpoint was response rate (RR) and secondary endpoints were time to progression (TTP), overall survival (OS) and safety profile. Tumor response was measured according to RECIST version 1.1. Toxicity was evaluated according to Common Toxicity Criteria of the National Cancer Institute.

      Results
      50 patients (29 male and 21 female) were included with a median (range) age of 67 years (46-82). The majority of patients had an Eastern Cooperative Oncology Group performance status of 1; median time off first-line treatment was 12 weeks. Average number of treatment cycles was 4 (range 1-6). Evaluable for response and toxicity were 45 and 48 patients, respectively. A complete response was achieved in 1 patient, a partial response in 24 patients, stable disease in 16 patients, and progressive disease in 4 patients (RR 73.5%; 95% confidence interval, 59 to 88). Median time to progression was 133 days (range 89-177). Median overall survival was 198 days (range 77-322). One-year survival rate was 34%. Hematologic toxicity grade 3 and 4 was leukopenia 19% and 8%, thrombocytopenia 10% and 2%, and anemia 4% and 0%, respectively, in a total of 186 cycles. Nonhematologic toxicity was diarrhea grade 3-4 (15%), stomatitis grade 3 (4%) and hyponatriemia grade 3 and 4 in one patient each. Seven patients were hospitalized due to neutropenic fever; no toxic deaths occurred.

      Conclusion
      Second-line DC in refractory or relapsing SCLC patients yielded a high RR and toxicity was relatively mild in these poor-prognosis patients. NCT00686985