Maintenance therapy in in Metastatic NSCLC. Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai

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1 Maintenance therapy in in Metastatic NSCLC Dr Amit Joshi Associate Professor Dept. Of Medical Oncology Tata Memorial Centre Mumbai

2 Definition of Maintenance therapy The U.S. National Cancer Institute s medical dictionary defines maintenance therapy as any treatment that is given to keep cancer from progressing after it has been successfully controlled by the appropriate front-line therapy; it may include treatment with drugs, vaccines or antibodies, and it should be given for a long time.

3 Limitations of the traditional approach and need of additional therapy 100 pts treated with 1st-line platinum doublet chemo ~75 pts obtain clinical benefit (CR/PR/SD) Watch and wait (2 3 months) ~38 pts receive 2nd-line therapy Many patients receive NO further therapy due to rapid deterioration in symptoms and performance status Stinchcombe and Socinski J Thoracic Oncol 2009

4 Maintenance in advanced NSCLC: The two approaches A Continuation maintenance 1 st line therapy (A + B ) 4-6 cycles Maintenance C Switch maintenance

5

6 Switch Maintenance : a) Erlotinib / Gefitinib b) Pemetrexed

7 ERLOTINIB IN MAINTENANCE

8 SATURN study: assessing the benefits of maintenance Erlotinib versus a treatment break Chemonaïve advanced NSCLC n=1,949 Mandatory tumour sampling 4 cycles of first-line platinum doublet chemotherapy* Non-PD n=889 Erlotinib 150mg/day 1:1 Placebo PD PD Subsequent therapy Subsequent therapy Stratification factors EGFR IHC (positive vs negative vs indeterminate) Stage (IIIB vs IV) ECOG PS (0 vs 1) CT regimen (cis/gem vs carbo/doc vs others) Smoking history (current vs former vs never) Region Co-primary endpoints PFS in all patients PFS in patients with EGFR IHC+ tumours Secondary endpoints OS in all patients and those with EGFR IHC+ tumours; OS and PFS in EGFR IHC tumours; biomarker analyses; safety; time to symptom progression; QoL *Cisplatin/paclitaxel; cisplatin/gemcitabine; cisplatin/docetaxel; cisplatin/vinorelbine; carboplatin/gemcitabine; carboplatin/docetaxel; carboplatin/paclitaxel

9 There is 41% improvement in PFS with maintenance Erlotinib (ITT) PFS probability Erlotinib (n=437) Placebo (n=447) PFS at 12 weeks (%) PFS at 6 months (%) Median (weeks) Mean PFS (weeks) HR=0.71 ( ) Log-rank p< Time (weeks) PFS is measured from time of randomisation into the maintenance phase; assessments were every 6 weeks Cappuzzo F, et al. J Clin Oncol 2009; 27(Suppl. 15):407s (Abs. 8001);

10 PFS according to EGFR mutation status EGFR mutation+ EGFR wild-type HR=0.10 ( ) Log-rank p< Erlotinib (n=22) Placebo (n=27) HR=0.78 ( ) Log-rank p= Erlotinib (n=199) Placebo (n=189) PFS probability Time (weeks) Time (weeks) Interaction p<0.001

11 Significant 23% increase in OS with maintenance Erlotinib (ITT) OS probability Erlotinib (n=438) Placebo (n=451) OS at 12 months (%) OS at 24 months (%) Median (months) HR=0.81 ( ) Log-rank p= Time (months) OS is measured from time of randomisation into the maintenance phase Cappuzzo F, et al. J Thorac Oncol (9 Suppl. 1):S289 (Abs. A2.1); F. Hoffmann-La Roche, data on file

12 Consistent OS benefit across clinical subgroups HR (95% CI) n All 0.81 ( ) 889 Male Female 0.88 ( ) ( ) 230 Caucasian Asian 0.86 ( ) ( ) 131 Adenocarcinoma Squamous-cell 0.77 ( ) ( ) 360 Never smoker Former smoker Current smoker 0.69 ( ) ( ) ( ) Favours Tarceva HR Favours placebo Cappuzzo F, et al. EJC Supplements 2009;7(3):13 (Abs. 22LBA)

13 Maintenance Erlotinib was well tolerated Erlotinib-related AEs occurring in 10% of patients Erlotinib (n=433) Placebo (n=445) Rash (%) 60 8 Grade Grade Diarrhoea (%) 18 3 Grade Grade 4 0 0

14

15 PEMETREXED AS SWITCH MAINTENANCE

16

17 Progression-free Survival (Intent-to-treat Population)* Progression-free Probability PEM 4.3 months PLA 2.6 months HR=0.50 (95% CI: ) p< Time (months) *Based on the ITT population, assessed by investigators (N=663). CI=confidence interval; HR=hazard ratio; PEM=pemetrexed; PLA=placebo.

18 Overall Survival (Intent-to-treat Population)* Survival Probability PLA 10.6 months HR=0.79 (95% CI: ) p=0.012 PEM 13.4 months Time (months) *Based on the ITT population, assessed by investigators (N=663). CI=confidence interval; HR=hazard ratio; PEM=pemetrexed; PLA=placebo.

19 Progression-free Survival - Nonsquamous (Intent-to-treat Population)* Progression-free Probability PLA 2.6 months HR=0.44 (95% CI: ) p< PEM 4.5 months Time (months) *Based on the ITT population, assessed by investigators (N=663). CI=confidence interval; HR=hazard ratio; PEM=pemetrexed; PLA=placebo.

20 Overall Survival - Nonsquamous (Intent-to-treat Population)* Survival Probability HR=0.70 (95% CI: ) p=0.002 PEM 15.5 months PLA 10.3 months *Based on the ITT population, assessed by investigators (N=663). CI=confidence interval; HR=hazard ratio; PEM=pemetrexed; PLA=placebo. Time (months)

21 Continuation Maintenance: a) Bevacizumab b) Cetuximab c) Pemetrexed d) Docetaxel e) Gemcitabine

22 BEVACUZUMAB AS MAINTENANCE

23 ECOG 4599: Phase III Trial of Bevacizumab in Nonsquamous NSCLC Treatment-naive patients with confirmed stage IIIB or IV cancer; adequate hematologic, hepatic, and renal function (N = 878) *Eligible patients included in analysis. PC Paclitaxel 200 mg/m 2 Carboplatin AUC = 6 mg/ml/min (once every 3 weeks) x 6 cycles (n = 433*) Stratified by RT vs no RT, stage IIIB or IV vs recurrent, weight loss < 5% vs 5%, measurable vs nonmeasurable PCB PC (once every 3 weeks) x 6 cycles + Bevacizumab 15 mg/kg (once every 3 weeks) until disease progression (n = 417*) Sandler A, et al. N Engl J Med. 2006;355:

24 E 4599: Overall Survival Median Survival (months) BCP (N = 434) CP (N=444 ) year Survival (%) year Survival (%) Sandler et al. NEJM 2006, 355:

25

26

27 FLEX: Phase III Evaluation of Cetuximab Plus Chemotherapy Advanced-stage, previously untreated NSCLC patients with EGFR+ in 1 tumor cell and no brain metastases (N = 1125) Cisplatin 80 mg/m 2 on Day 1 Vinorelbine 25 mg/m 2 on Days 1 and 8 Six 3-wk cycles Cetuximab 400 mg/m 2 over 2 hrs on Day mg/m 2 over 1 hr wkly from Day 8 Continued until disease progression Cisplatin 80 mg/m 2 on Day 1 Vinorelbine 25 mg/m 2 on Days 1 and 8 Six 3-wk cycles Primary endpoint: OS Secondary endpoints: PFS, RR, QoL, safety Pirker R, et al. Lancet. 2009;373:

28 FLEX: Efficacy Outcomes Outcome Cisplatin/ Vinorelbine + Cetuximab (n = 557) Cisplatin/ Vinorelbine (n = 568) HR (95% CI) Median OS, mos ( ) Median PFS, mos ( ) Median TTF, mos ( ) P Value Response rate, % Pirker R, et al. Lancet. 2009;373:

29 PEMETREXED AS CONTINUOUS MAINTENANCE THERAPY

30

31 PARAMOUNT: Drug Administration Maintenance Phase Pemetrexed (N=359) Placebo (N=180) Patients Treated* Number of Cycles/Patient Median 4 4 Range Mean Patients Completing > 6 Cycles 37% 18% Dose Intensity of Planned Mean Dose 93.7% NA Median Follow-up, months (95% CI) For all Patients 12.5 ( ) For all Alive Patients 24.3 ( )

32

33

34 Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo [16%] vs [4%]; p<0 0001), specifically fatigue (22 [5%] vs one [1%], p=0 001) and neutropenia [3%] vs 0, p=0 006). No pemetrexed-related deaths occurred.

35 Docetaxel as maintenance

36 Docetaxel as Maintenance therapy

37 Gemcitabine as Maintenance

38 Gemcitabine as maintenance therapy

39

40

41

42 Is there any clinical criteria to select the patient for maintenance chemotherapy?

43

44

45 The Committee for Medicinal Products for Human Use (CHMP) adopted a new indication as follows: Erlotinib is indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after four cycles of standard platinum-based first-line chemotherapy. When prescribing Erlotinib, factors associated with prolonged survival should be taken into account.

46 TAKE HOME MESSAGE Maintenance chemotherapy in NSCLC improves PFS and OS ( Both Switch and continuous). ( Level of Evidence: I A ) Erlotinib as maintenance therapy in NSCLC. ( Level of Evidence: I A ) In non Squamous NSCLC, Pemetrexed is the preferred agent as maintenance. ( Level of Evidence: I A )

47 TAKE HOME MESSAGE Bevacizumab as maintenance improves PFS in Non Squamous histology. ( Level of Evidence: IA ) In Unselected population of NSCLC Docetaxel or Gemcitabine can be used as maintenance, but due to increased toxicity and modest benefit, this is not used routinely. ( Level of Evidence II B )

48 THANK YOU

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