1 / 24

Adjuvant Therapy of NSCLC Winter Lung Cancer Conference 2012

colman
Download Presentation

Adjuvant Therapy of NSCLC Winter Lung Cancer Conference 2012

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Please note, these are the actual video-recorded proceedings from the live CME event and may include the use of trade names and other raw, unedited content. Select slides from the original presentation are omitted where Research To Practice was unable to obtain permission from the publication source and/or author. Links to view the actual reference materials have been provided for your use in place of any omitted slides.

  2. Adjuvant Therapy of NSCLCWinter Lung Cancer Conference2012 Rogerio Lilenbaum, MD, FACP Cleveland Clinic Florida Weston, FL

  3. Adjuvant Therapy of NSCLC • Stage IB • Chemotherapy choices • PORT

  4. T e s t f o r t r e n d : p = 0 . 0 5 1 LACE – Benefit by Stage CT may be detrimental for stage IA, but stage IA patients were generally not given cisplatin+vinorelbine (13% of stage IA patients versus ~43% for other stages)

  5. CALGB 9633 Overall Survival by Tumor Size Tumor ≥4 cm Tumor <4 cm • Chemotherapy (N = 99) • Control (N = 97) • HR = 0.69 • 90% CI: 0.48 to 0.99 • P = .043 • Chemotherapy (N = 63) • Control (N = 71) • HR = 1.12 • 90% CI: 0.75 to 1.07 • P = .32 Strauss Proc ASCO 2004 abs 7019, 2006 abs 7007, JCO 2008

  6. Stage IB Analysis Strauss JCO 2008, Vincent ASCO 2009

  7. Stage-Specific Hazard RatiosRecent Adjuvant Trials Positive Negative Indeterminate Not studied

  8. Adjuvant Therapy of NSCLC Stage IB Tumor size matters Use 4 cm as a parameter Chemotherapy choices PORT

  9. Adjuvant Therapy of NSCLC Stage IB Chemotherapy choices PORT

  10. E1505 Chemotherapy Regimens Therapy to start 6-12 weeks post-operatively Investigator Choice of Chemo - 4 cycles (12 wks) Cisplatin/Vinorelbine Cis 75 mg/m2 d1, Vin 25 mg/m2 d1,8 q21 d Cisplatin/Docetaxel Cis 75 mg/m2 d1, Docetaxel 75 mg/m2 d1 q21 d Cisplatin/Gemcitabine Cis 75 mg/m2 d1, Gem 1250 mg/m2 d1,8 q21 d Cisplatin/Pemetrexed Cis 75 mg/m2 d1, Pem 500 mg/m2 d1 q21 d

  11. E1505 – Adjuvant ChemotherapyWakelee et al - ASCO 2011 • Between Aug 2007 and Jan 2010, 557 patients were enrolled: • median age 61 • 52% female • 54% adeno, 31% squamous • 23% IB, 43% II, 29% IIIA (N2) , 4% IIIA (T3N1) • Adjuvant regimens: • 28% C-V • 34% C-D • 26% C-G • 12% C-P (added later) • Overall Gr 3/4 toxicities are increased in Bev arm; Gr 5 toxicity was 2.5% vs. 3.8% without or with Bev

  12. TREAT Design Cisplatin / Vinorelbine (CVrb) 50 mg/m2 d1+8 / 25 mg/m2 d1, 8, 15, 22 q d 29 x 4 Cisplatin / Pemetrexed (CPx) 75 mg/m2 d1 / 500 mg/m2 d1 q d 22 x 4 • Rationale: • Need: reduction of toxicity, improvement of dose delivery & compliance • Cisplatin / pemetrexed in thoracic malignancies: high dose intensity, low toxicities Inclusion: • NSCLC stages IB, IIA, IIB, T3N1M0 • ≤ 42 Tage postoperatively, R0, systematic LN-dissection • ECOG 0, 1 - amenable to cisplatin treatment Winton et al., N Engl J Med (2005) 352: 258 R0

  13. Results Primary endpoint - feasibility p = 0.0010 * multiple reasons possible

  14. Results End of therapy **delay >2 weeks due to toxicity or in case of G3/4 non-hem toxicity *multiple reasons possible

  15. TREAT: Time to treatment failure • Time from surgery to withdrawal due to • AE • progression / relapse / death • failure to return to therapy • refusal of treatment / withdrawal of consent Time to treatment failure also in favor of cisplatin/pemetrexed, p<0.001

  16. Adjuvant Therapy of NSCLC Stage IB Chemotherapy choices Use cisplatin whenever possible Cis-Vnb is associated with greater toxicity PORT

  17. Adjuvant Therapy of NSCLC Stage IB Chemotherapy choices PORT

  18. ANITA - PORT Evaluation Rosell, IASLC 11, Abs Pr3, 2005 PORT: 33% on obs, 22% on chemo For all chemo > XRT = chemo/XRT > 0 For N2 chemo/XRT > chemo > XRT > 0

  19. Overall survival for N2 pts stratified by postoperative radiotherapy (PORT) use – SEER data There is benefit of PORT in stage IIIA-N2 disease, and the role of PORT in early stages of NSCLC should be clarified in ongoing phase III trials.

  20. “Lung ART”P.I. Dr Cécile Le Pechoux S U R G E R Y Conformal RT 54 Gy/27-30 fxs No post-op RT Completely resected N2 NSCLC Primary end-point: DFS (sample size: 700 patients) Pre or post-op chemotherapy allowed Concomitant chemo not allowed Sponsors: FNCLCC, IFCT, LARS-G, EORTC

  21. Adjuvant Therapy of NSCLC Stage IB Chemotherapy choices PORT No benefit in N0 and N1 disease Consider in N2 patients – especially with multi-station involvement and/or extra-capsular spread Do it sequentially

  22. Sunday, February 12, 2012Hollywood, Florida Co-Chairs Rogerio C Lilenbaum, MD Mark A Socinski, MD Co-Chair and Moderator Neil Love, MD Faculty Walter J Curran Jr, MD David Jablons, MD Mark G Kris, MD Suresh Ramalingam, MD Alan B Sandler, MD

More Related