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B. Massuti
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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)
17:00 - 17:06 | Author(s): B. Massuti
- 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)
11:30 - 11:36 | Author(s): B. Massuti
- 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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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-045 - Safety of Bevacizumab (B) in Elderly Stage IV Non-Squamous NSCLC Patients Selected by Geriatric Assessment: A Phase II Study (ID 5518)
14:30 - 14:30 | Author(s): B. Massuti
- Abstract
Background:
The addition of B to platinum-doublet chemotherapy in first-line treatment for non-squamous NSCLC showed improvement of progression free survival (PFS) and overall survival (OS) (ECOG 4599). However, in a subset analysis of this trial, grade 3 to 5 toxicities occurred more frequently in elderly patients treated with CPB compared with patients treated with CP and in elderly patients compared with younger patients. Grade 3/4 neutropenia was 34% in elderly patients. GIDO1201 is the first trial addressed specifically to assess the safety of B in elderly patients. We hypothesized that an adjusted dose-regimen administered to elderly patients selected by an adapted geriatric assessment could decrease the rate of neutropenia to 20%.
Methods:
Elderly (≥70 years old) chemotherapy-naive stage IIIB/IV or recurrent non-squamous NSCLC patients, ECOG-PS 0-1, measurable target lesion, and adequate organ functions were eligible for this study. After an Adapted Geriatric Assessment, elderly patients with NSCLC received a modified regimen consisting on triweekly C AUC 4 + P 175 mg/m[2] + B 7.5 mg/kg
Results:
Twenty-six eligible patients (20 male, 6 female; median age, 76 years) were enrolled between August 2013 and June 2015. Six and 20 patients had ECOG-PS of 0 and 1, respectively. The median number of CPB treatment cycles received was 4 (2-6). 17 patients (66%) received B maintenance (median number of cycles 7). At the time of analysis, 3 patients are still on treatment. Grade 3/4 neutropenia was observed only in one patient (3.8%). Grade 3/4 non-haematological and haematological toxicities were observed in 10 (38.5%) and 4 (15.4%). pts, respectively. The most common grade 3/4 AEs included anaemia (11.5%) and hypertension (15.4%). One fatal AE was observed. At the time of this preliminary analysis, median PFS was 8.22 months (6.0-10.3) and median OS was 11.6 (8.0-15.1)
Conclusion:
CPB triweekly followed by BEV showed an acceptable toxicity profile with a favourable grade 3-4 neutropenia of 3.8% compared with previously reported. Efficacy of this first-line regimen for selected elderly non-squamous NSCLC patients was similar to younger patients. However, this study has the limitation of the small number of patients, although a simple size of 51 patients was needed to test this hypothesis, the study was halted after the inclusion of 26 patients due to the slow recruitment.
