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J. Bennouna
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MO06 - NSCLC - Chemotherapy I (ID 108)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:R. Perez-Soler, P.M. Ellis
- Coordinates: 10/28/2013, 16:15 - 17:45, Parkside Ballroom A, Level 1
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MO06.06 - Oral vinorelbine (NVBo) and cisplatin (P) or pemetrexed (Pem) and P as first-line chemotherapy for non squamous (NS) metastatic or locally advanced non small cell lung cancer (M or LA NSCLC): Final results of a prospective randomised phase II trial (NAVoTrial 1) (ID 276)
16:15 - 17:45 | Author(s): J. Bennouna
- Abstract
- Presentation
Background
NVBo and P are an established regimen in advanced NSCLC. The approval of Pem and P in NS NSCLC recognises histology as treatment driver even if the higher chemosensitivity of NS NSCLC is recognised and reported with other chemotherapies (Ardizzoni. JNCI 2007). NVBo + P also showed better survival in NS NSCLC than in Squamous NSCLC (Tan. Ann.Oncol. 2009). The current randomised (2:1) phase II trial assessed disease control (DCR) (SD + PR + CR) of NVBo/CDDP or PEM/CDDP in NS NSCLC.Methods
Stage IIIB/IV untreated/relapsed NS NSCLC pts were randomised to receive q3w NVBo 80 mg/m² D1D8 (60 at Cycle 1) + P 80 mg/m² D1 (Arm A) or Pem 500 mg/m² + P 75 mg/m² D1 (Arm B). After 4 cycles of combination, non PD pts received single agent NVBo (Arm A) or PEM (Arm B) as maintenance until progression or toxicity. Pts were randomised on a 2/1 basis and stratified according to Stage (IIIB - IV - relapse), non SCC confirmed by histology or cytology, gender, smoking status and centre.Results
From 11/09 to 02/11, 153 patients were enrolled in 31 centers and randomised to Arm A (102 pts) or Arm B (51 pts). DCR after combination and maintenance was 75.0% (95% CI, 65.3 to 83.1) in Arm A and 76.5% (95% CI, 62.5 to 87.2) in Arm B. Median PFS was 4.2 (95% CI, 3.6 to 4.7) and 4.3 months (95% CI, 3.8 to 5.6) in Arm A and Arm B, respectively. Median OS was 10.2 months (95% CI, 7.8 to 11.9) and 10.8 months (95% CI, 7.0 to16.4) in Arm A and Arm B, respectively. During the combination period Grade 3/4 neutropenia was 44.0% in Arm A and 18.3% in Arm B but febrile neutropenia was 2% in both arms; grade 3/4 thrombopenia was 0% and 6% in Arm A and Arm B, respectively.Conclusion
Both doublets reported good efficacy and acceptable tolerability. The maintenance allowed continuation of effective treatment with either oral vinorelbine or pemetrexed as single agent, with an acceptable safety with both agents. These results are sufficiently compelling to consider whether a phase III randomised non inferiority study with oral vinorelbine maintenance after induction vinorelbine/cddp could be as effective as pemetrexed maintenance. An oral maintenance may be a definite advantage over intravenous maintenance.Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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O21 - SCLC II (ID 119)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:M. Ahn, P. Lara
- Coordinates: 10/29/2013, 16:15 - 17:45, Parkside Ballroom B, Level 1
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O21.06 - MLN8237 (alisertib), a selective Aurora A Kinase (AAK) inhibitor, in patients with relapsed/refractory small cell lung cancer (SCLC): Phase 2 results (ID 2815)
16:15 - 17:45 | Author(s): J. Bennouna
- Abstract
- Presentation
Background
AAK, a key mitotic regulator, plays an important role in carcinogenesis. AAK is frequently overexpressed/amplified in a variety of human cancers. Inhibition of AAK has been associated with tumor inhibition in SCLC patients; thus, AAK is an attractive target in SCLC treatment. The investigational, oral, selective AAK inhibitor MLN8237 is under evaluation in patients with advanced hematologic and non-hematologic malignancies. A phase 1/2 study (NCT01045421) evaluated MLN8237 in patients with solid tumors; phase 2 data for the SCLC cohort are presented.Methods
Patients aged ≥18 years with relapsed/refractory SCLC, ECOG PS 0–1, and ≤2 prior cytotoxic chemotherapy regimens were eligible (symptomatic and untreated brain metastases were excluded); sensitive and resistant/refractory was defined as recurrence > or ≤90 days of frontline therapy respectively. MLN8237 50 mg was administered twice-daily for 7 days (21-day cycles). Using a Simon’s optimal 2-stage design, ≥2 objective responses were required in the first 20 response-evaluable patients to proceed to the expansion stage. Primary objective: overall response rate (ORR) by RECIST v1.1. Secondary objectives: safety, duration of response (DOR), and progression-free survival (PFS). Exploratory studies included whole-exome sequencing in banked tumor specimens to identify genetic markers/mutated pathways associated with differential response.Results
As of April 2013, 60 patients were enrolled; median age, 62 years (range 43–76); median number of cycles 2 (range 1–15). 48 patients (80%) were response-evaluable (chemo-sensitive, n=36; chemo-refractory, n=12). Prior lines of therapy and efficacy data are shown in the table. ORR was 21%, median PFS 2.11 months. Most common grade ≥3 drug-related AE included neutropenia (53%) and febrile neutropenia (8%); all AEs were reversible.14 patients discontinued due to AEs (treatment-related in 3 patients: hyponatremia, thrombocytopenia, acute generalised exanthematous pustulosis; each, n=1). 13 on-study deaths were reported; none were considered drug-related (most frequent cause was disease progression [n=6]). Whole-exome sequencing of selected tumor samples was completed. Preliminary results will be presented.Conclusion
MLN8237 has a generally manageable toxicity profile; data from this study suggests it has single agent antitumor activity in SCLC patients with sensitive or resistant-refractory relapse, supporting further evaluation of MLN8237 in different combination strategies in this tumor type.
* Numbers of events: 7; **Not enough events to give meaningful estimates.All Chemo-sensitive Chemo-refractory Prior lines of therapy First line, n (%) N=48 n=36 n=12 Platinum/etoposide 45 (94) 33 (92) 12 (100) Other 3 (6) 3 (8) – Second line, n (%) N=23 n=19 n=4 Rechallenge 13 (57) 12 (63) 1 (25) Topotecan 3 (13) 2 (11) 1 (25) Other 7 (30) 5 (26) 2 (50) Efficacy data N=48 n=36 n=12 Median cycles (range) 2.5 (1–15) 3.5 (1–15) 2 (2–6) Best response, n (%) ORR (PR) 10 (21) 7 (19) 3 (25) SD 16 (33) 13 (36) 3 (25) PD 22 (46) 16 (44) 6 (50) Median DOR (months) 4.1* –** –** Median PFS (months) 2.11 2.58 1.74 Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
