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B. Campos



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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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      P1.13-005 - Paclitaxel and Irinotecan in Platinum Refractory or Resistant Small Cell Lung Cancer: a Galician Lung Cancer Group experience. (ID 2340)

      09:30 - 09:30  |  Author(s): B. Campos

      • Abstract

      Background
      Patients with Small Cell Lung Cancer (SCLC) whose disease progresses during or shortly after treatment with platinum, have a poor prognosis. Paclitaxel (P) and irinotecan(I) have demonstrated activity both as monotherapy as in combination regimen for this neoplasm. We present preliminary data from our experience in patients with SCLC refractory or resistant to platinum.

      Methods
      We included patients with measurable disease that had progressed during or within six months of first-line chemotherapy based on platinum, with an Eastern Cooperative Oncology Group (ECOG) performance status <2, adequate liver, renal and bone marrow function. They were treated with (P): 75 mg/m2 and (I): 50 mg/m2, both drugs administered on days 1 and 8 of a 21 day cycle. Treatment was maintained until disease progression and/or unacceptable toxicity.

      Results
      We included 24 patients with a mean age of 59.5 years (43-79) and with metastases in two or more locations in 21 of them (87.5%). A median of 4 cycles of treatment was administered and eight patients (33.3%) received six or more cycles. The main reason for discontinuation of chemotherapy was disease progression, observed in 20 patients (83.3%). Partial response was documented in 16 patients (66.6%), stable disease in three (12.5%) and disease progression in five (20.8%). The median survival time was 24,9 weeks and the 1-year survival time was 22%. There have been no treatment-related deaths. The clinical and hematologic toxicities most frequently observed were grade 1 and 2: nausea (n:7; 29,2%), asthenia (n:7; 29,2%), anorexia (n:6; 25%), diarrhea (n:4; 16,6%), anemia (n:16; 66,6%) and neutropenia (n:12; 50%). There was one (4,1%) grade 4 and two (8,3%) grade 3 neutropenia. There were no cases of grade 4 clinical toxicity and there were eight (33,3%) grade 3 : three of diarrhea (12,5%), two hepatic (8,3%) and three of asthenia (12,5%).

      Conclusion
      This (P) and (I) regimen is an effective and well tolerated option for this subgroup of poor prognosis patients with SCLC. We still continue including patients in this protocol, which ensures future communications of the same.

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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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      P2.09-003 - Concurrent Chemoradiation (CChRT) for stage III Non-Small Cell Lung Cancer (NSCLC): a phase II study from the Galician Lung Cancer Group. (ID 1010)

      09:30 - 09:30  |  Author(s): B. Campos

      • Abstract

      Background
      Combined cytotoxic chemotherapy and radiation therapy is established as the standard treatment for patients with medically inoperable or technically unresectable stage III NSCLC. Multiple randomized studies and meta-analyses demonstrate that CChRT results in improved survival compared with sequential chemo-radiotherapy or radiotherapy alone. The aim of our study was to evaluate the effectiveness and toxicities of CChRT with bi-weekly Docetaxel (D) and Cisplatin (C) and thoracic radiotherapy, after one cycle D-C induction chemotherapy.

      Methods
      Between May 2009 and November 2012, 53 chemo-naive p with histologically confirmed inoperable locally advanced NSCLC, stage IIIAN2/IIIB (no pleural T4), PS 0-1 and adequate lung function (FEV1 > 1.1, V20 < 25%) were included: one cycle of D 75 mg/m2 on day 1 and C 40 mg/m2 days 1-2 followed at 21 days by CChRT with bi-weekly D 40 mg/m2 and C 40 mg/m2 for four courses, during conformal thoracic radiotherapy (66 Gys, 180 cGy/day). The primary objective was overall survival (OS); secondary objectives were progression free survival (PFS), response rate (RR) and toxicity. Median follow-up: 17,8 months.

      Results
      The p characteristics were: mean age 59,4 years (34-75); male/female 47/6; ECOG PS 0/1 in 17/36 p; squamous/adeno/large cell carcinoma: 53%/34%/13%; stage IIIAN2 15 p (28.3%) and stage IIIB 38 p (71.7%). All p were evaluable for response and toxicity. RR: 6 CR, 37 PR (RR 81.8%; 95% CI:71-92), 4 SD (7.6%) and 6 PD (11.3%). The median PFS was 14 months (95% CI:11-17) and median OS was 21 months (95% CI:9-32). The PFS at 1/2 years were 55%/32% and the OS at 1/3 years were 82%/50%. A total of 53 cycles of D-C induction chemotherapy were given; main toxicities (NCI-CTC 3.0) per p Grade (g) 1-2/3-4 (%) were as follows: neutropenia 1.8/15; anemia 11.3/0; nausea/vomiting 26.4/1.8; diarrhea 22.6/3.7; fatigue 35.8/0; there were three episodes of hospitalization: febrile neutropenia 2 p and g3 diarrhea 1p. Main toxicities per p in CChRT (D-C doses: 203, 3.8 per p; mean doses RT: 64,6 Gys) were g1-2/3 (%): neutropenia 28.3/5.6; anemia 62.2/0; esophagitis 50.9/3.7 and pneumonitis 32/0; nausea/vomiting 20.7/0; fatigue 37.7/3.7; there were four episodes of hospitalization: febrile neutropenia, 2 p and g3 esophagitis, 2 p.

      Conclusion
      CChRT with bi-weekly Docetaxel and Cisplatin and thoracic radiotherapy is a feasible treatment option for inoperable locally advanced stage III NSCLC, showing good clinical efficacy and tolerability with acceptable long-term survival.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P3.11-019 - Gefitinib efficacy in EGFR mutated Non Small Cell Lung Cancer (NSCLC) patients based on type of mutation: a study from the Galician Lung Cancer Group. (ID 1710)

      09:30 - 09:30  |  Author(s): B. Campos

      • Abstract

      Background
      Screening for Epidermal Growth Factor Receptor (EGFR) mutation is a key molecular test for management of lung cancer. Patients who respond well to an EGFR inhibitor harbor certain mutations in the EGFR exons 18, 19 or 21. An additional mutation in EGFR exon 20 is known to be responsible for acquired resistance to this therapy.

      Methods
      We conducted an analysis of Galician advanced lung cancer patients who were tested positive for EGFR kinase domain mutations determination and were treated with gefitinib. Frequency and type of EGFR mutations and the clinical response in our area were explored. The aim is to analyse the pattern of response, toxicity, progression free survival and overall survival based on the type of EGFR mutation.

      Results
      Forty-six patients with EGFR mutations were collected, 36 women and 10 men. The median age was 67 years (43-86). Majority of the patients in the study had PS 0-1 (93%) and adenocarcinoma (96%) in the pathological study. The most frequent sites of metastasis were lymph nodes (59%), bones (33%), lung (33%) and pleura (33%). The median duration of treatment was 6 months. Progression disease was the most frequent reason of discontinuation of gefitinib; in 9 patients was discontinued because of toxicity. Ten patients were switched to cytotoxic chemotherapy and 10 patients continued with erlotinib. Twenty patients were detected to be positive for mutation in exon 19, 4 patients in exon 20 and 20 patients in exon 21. The L858R point mutation in exon 21 was observed in 14 patients and the L833F point mutation in the same exon was observed in 1 patient. Thirty-five patients were included in the response analysis. The response ratio to gefitinib was 57%. Depending on the type of mutation, the response in exon 19 mutation patients was 64%, in exon 20 patients was 0% and in exon 21 patients was 60%. Rash or acne was the most frequent toxicity (48%), only 2% was grade 3-4. Diarrhea and dysnea were the main toxicities grade 3-4 (9% both), without statistical differences based on type of mutation (p=0.78) . Progression free survival (PFS) of patients with EGFR mutations was 6 months. Patients with mutation in exon 19 had 9 months compared to 6.4 months for patients with exon 21 mutation, presenting a statistically significance difference (p=0.002). Overall survival (OS) was 17 months for EGFR mutations patients (19 months for exon 19 mutation patients and 14 months for exon 21 mutation patients; p=0.119)

      Conclusion
      Pacients in our area with exon 19 EGFR kinase domain mutations treated with gefitinib have higher PFS compare to exon 21 EGFR kinase domain mutations. Exon 20 mutation in our patients is responsible for resistance to gefitinib.

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      P3.11-021 - Bevacizumab (B) (10 mg/Kg) in combination with Cisplatin (C) and Docetaxel (D) administered every 2 weeks in patients (p) with advanced non-squamous Non-Small Cell Lung Cancer (nsNSCLC): GGCP047/10 study. (ID 1926)

      09:30 - 09:30  |  Author(s): B. Campos

      • Abstract

      Background
      B in combination with platinum doublets followed by continuation maintenance with B prolongs survival and delays progression in chemo-naïve pts with advanced nsNSCLC. In a phase II trial C, D and B (15 mg/kg) every 3 weeks followed by B showed a promising efficacy, in terms of progression free survival (PFS) and overall survival (OS), and an acceptable toxicity profile. In addition, a biweekly schedule of D and C in p with metastatic NSCLC as a front-line CT has demonstrated effective antitumor activity with a reduction in hematologic toxicity, comparable to the results of previous studies using 3-week schedule. Taken together, these data suggest that the addition of B to C/D administered every 2 weeks could increase the efficacy and reduce the toxicity associated with the other schedules.

      Methods
      GGCP 047-10 is a multicenter study in chemo- naïve p diagnosed with advanced nsNSCLC. Eligible p also have measurable disease according to RECIST criteria; age ≥18 years; ECOG PS ≤1; adequate hematological, renal and liver function; life expectancy of at least 2 months and signed informed consent. P receive C (50 mg/m2), D (50 mg/m2), and B (10 mg/kg) every 2 weeks for up to 6 cycles, followed by B alone every 2 weeks until disease progression or unacceptable toxicity. PFS is used as the primary efficacy endpoint. Secondary endpoints include safety profile, overall response rate (ORR), disease control rate (DCR) and OS.

      Results
      32 p were enrolled in the study. Median age was 60 years (range 44-72; 28.1% > 65 years); male/female (%): 81/19; ECOG 0/1/2 (%): 28/63/10; adenocarcinoma (%): 84. Median PFS in overall population was 6.4 months (95% CI, 4.2-8.7). Among the 22 p evaluable for response, the ORR was 63.6% and DCR was 95.4%. Most frequent grade 3/4 hematologic toxicity was neutropenia (40.6%) and grade 3/4 nonhematologic toxicities was asthenia (12.5%) followed by mucositis (6.2%) and diarrhea (3.1%). There were no grade 3/4 hemorrhagic events.

      Conclusion
      Treatment with B, C and D plus maintenance B every 2 weeks is effective as front-line treatment of p with advanced nsNSCLC with acceptable toxicity. These data provide further evidence that B may be used in combination with multiple standard, platinum-based doublets in this setting.