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A. Insa Molla
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MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:P. Van Houtte, M. Zemanová
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 2
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MA06.09 - Efficacy RENO Study Results of Oral Vinorelbine or Etoposide with Cisplatin & Chemo-Radiation in Stage III NSCLC. SLCG 10/02 (ID 4238)
16:00 - 17:30 | Author(s): A. Insa Molla
- Abstract
- Presentation
Background:
This study aims to compare efficacy and safety of two widely used combinations of cisplatin (P) in this setting: as etoposide (E) and vinorelbine. This last, in its oral formulation (oV) which has achieved comparable results as the IV formulation and patients (pts) prefer it.
Methods:
Pts between 18-75years, with histologically proven untreated and unresectable locally-advanced NSCLC (LA-NSCLC), adequate respiratory function, V20≤35% and ECOG-PS 0-1, were randomized 1:1 to oV-P arm: 2 induction cycles (cy) of oV-P followed by 2 cy more with RT; or to E-P arm: 2 cy of E-P concomitants to RT. Both arms with a total radiation dose of 66Gy administered 2 Gys daily. Primary endpoint was progression free survival (PFS) by RECIST 1.1. Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety. With α-error of 0.05 (one-tailed test) and 0.1 β-error, median PFS unacceptable for the oV-P arm of 10 months (m) (p0) and a very acceptable of 15 m (p1), 122 eligible pts were required.
Results:
140 pts from 23 institutions of SLCG were randomized between 08/2011-12/2014. 134 pts were treated (66 in oV-P and 68 in E-P arms). Results based on this 134 pts are presented. Median age 62 years [39-76]; PS 0/1, 45%/55%; current smoker 51%; squamous cell 51%; stage IIIB 54%. 244 and 131 cy were given in the oV-P and E-P arms, respectively. All irradiated pts in oV-P arm received at least 60Gy, 7 pts in the E-P arm received less than 60Gy (4 due to toxicity). 1 pt (1.5%) in oV-P arm and 12 pts (17.6%) in E-P arm presented esophagitis G3/4 (p=0.002). 121 confirmed eligibility for efficacy analysis. ORR were 39 (64%) and 40 pts (67%) in the oV-P and E-P arms, respectively (p=0.889). After 16 m [1-43] of follow-up, 66% pts progressed and 43% pts died. Median PFS is 11.4 m (IC95%; 6-17) in oV-P arm and 11.8 m (IC95%; 7-16) in E-P arm (p=0.374).
Conclusion:
Both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4. Further follow-up is needed for the survival analysis.
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MA07 - ALK-ROS1 in Advanced NSCLC (ID 385)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
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MA07.05 - EUCROSS: A European Phase II Trial of Crizotinib in Advanced Adenocarcinoma of the Lung Harboring ROS1 Rearrangements - Preliminary Results (ID 4451)
11:00 - 12:30 | Author(s): A. Insa Molla
- Abstract
- Presentation
Background:
ROS1 rearrangements are present in the tumors of 1-2% of patients with lung adenocarcinoma (LAD). This patient subgroup is characterized by non-smoking history and younger than average age compared to the overall NSCLC population. In a phase I trial the ALK/ROS1/MET inhibitor crizotinib has shown to be highly effective in these patients (NCT00585195). EUCROSS is a prospective phase II trial of the Lung Cancer Group Cologne in collaboration with the Spanish Lung Cancer Group to evaluate crizotinib in ROS1-positive LAD. Here, we present preliminary data on efficacy and safety.
Methods:
Patients with advanced LAD harboring ROS1 rearrangements as confirmed by central FISH were eligible for the trial irrespectively of the number of prior treatment lines. Patients received treatment with crizotinib 250 mg BID - doses were adapted for management of AEs. Trial design: Fleming’s single stage phase II design. Primary endpoint: ORR (95% CI, H~0~: ORR≤20% vs. H~1~: ORR>20%). Secondary endpoints: a.o. PFS, OS and safety. All efficacy endpoints were assessed by investigator’s RECIST v1.1 and will be analyzed by IRB at a later stage. Baseline tumor tissue was analyzed by DNA-sequencing to identify the translocation Partners of ROS1, to validate FISH results and to identify additional biomarkers for prediction of response. Data-cut off for this report was March 2016.
Results:
In total, 34 patients were enrolled in EUCROSS at the time of data cut-off. Twenty-nine patients were eligible for efficacy assessment. Tumor tissue of 20 of these patients was suitable for further sequencing - 18 were sequenced positive for ROS1 fusion. The fusion partners involved were CD74 (N=9;50%), EZR (N=4;22%), SCL34A2 (N=3;17%), TPM3 and SDC4(N=1;6% each). The investigator assessed ORR was 69% (95% CI, 49.1-84.3) in the overall trial population and 83% (95% CI, 67.7-94.2) in the ROS1-positive by sequencing population (N=18;P=0.324 for difference of ORR). Three patients (10.3%;95% CI, 3.6-26.4) exhibited primary progression, two of them were sequenced ROS1-negative. All patients were included in the safety population (N=34). Most common AEs irrespectively of relatedness or grade were visual disorders (N=16;48%), edema (N=14;41%), diarrhea (N=13;38%) and bradycardia (N=11;32%).
Conclusion:
Crizotinib is a highly effective and safe treatment in the subset of ROS1 rearranged NSCLC patients as determined by FISH and DNA-sequencing. Although, the number of patients with tissue available for sequencing was low at the time of data cut-off, sensitivity and specificity support sequencing as the potential new gold-standard for the identification of clinically relevant ROS1 gene-rearrangements.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-084 - Predictive and Prognostic Clinical and Pathological Factors of Nivolumab Efficacy in Non-Small-Cell Lung Cancer (NSCLC) Patients (ID 5085)
14:30 - 15:45 | Author(s): A. Insa Molla
- Abstract
Background:
Immunotherapy with anti-PD1 and anti-PDL1 monoclonal antibodies significantly increases overall response rate (ORR) and overall survival (OS) of patients with advanced NSCLC in comparison with second line conventional chemotherapy. Prognostic and predictive factors able to distinguish those patients with a higher benefit from immunotherapy are warranted. Our work retrospectively analyses several clinical, pathological and analytical variables with an eventual potential prognostic and predictive value in daily patients with advanced NSCLC receiving Nivolumab.
Methods:
A retrospective review of clinical charts of patients with advanced NSCLC from fourteen centres of the GIDO group receiving Nivolumab between May-2015 and May-2016 was performed. Age, sex, stage, Performance Status (PS), location of metastases, presence of tumour-related symptoms and comorbidities, number of organs with metastasis, previous chemotherapy, antiangiogenic and radiotherapy treatments, and analytical data from standard blood count and biochemistry were collected and statistically analyzed.
Results:
A total of 175 patients fulfilled inclusion criteria. Median age was 61.5 years. One hundred and twenty-eight male (73.1%), 136 ECOG-PS 0-1 (77.7%), 150 stage IV (86,7%) and 135 had non-squamous carcinoma histology (77.1%). Sixty-five received Nivolumab in second line (37.1%), 66 as third line (37.1%) and 44 as forth or further line of treatment (25.1%). Seventeen patients (9.7%) received antiangiogenic drug in previous line of treatment, and 30 were treated with radiotherapy within 30 days before Nivolumab. Thirty-eight patients had brain metastasis (22%), 39 liver metastasis (22.3%) and 126 had more than one metastatic location (72%). 140 patients were evaluable for response, the ORR was 15.7%, median Progression Free Survival was 2.8 months, and median OS 5.81 months. Stage III (OR 3.57) and time since the beginning of previous line of treatment longer than 6 months (OR 2.52) were associated in multivariable analysis with higher probability of response to Nivolumab. PS 2 vs 0-1 (HR 1.83), time since the beginning of previous line of treatment <6 vs >6 months (HR 1,70) and more than one metastatic location vs one location (HR 1.79) were independently associated with shorter overall OS in multivariable analysis.
Conclusion:
Poor Performance Status, short period of time since the beginning of previous treatment and more than one metastatic location are the clinical-pathological features associated with poorer prognostic in patients with advanced NSCLC treated with Nivolumab. Limitations of the study are the small numbers and the retrospective nature
