Chemotherapy Prolongs Survival for Isolated Local or Regional Recurrence of Breast Cancer: The CALOR Trial

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1 Chemotherapy Prolongs Survival for Isolated Local or Regional Recurrence of Breast Cancer: The CALOR Trial S. Aebi, S. Gelber, I. Láng, S.J. Anderson, A. Robidoux, M. Martín, J.W.R. Nortier, E.P. Mamounas, C.E. Geyer, Jr., R. Maibach, R.D. Gelber, N. Wolmark, I. Wapnir, for the CALOR Trial Investigators Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer. IBCSG 27 02, NSABP B 37, BIG 1 02 (BOOG, GEICAM, IBCSG) This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute.

2 Disclosures None

3 Background Isolated local or regional recurrence (ILRR) of breast cancer predicts a poor prognosis Three trials of adjuvant drug therapy have been completed Fentiman ( ): α-interferon, N=32 SAKK ( ): Tamoxifen, N=178 Olsen ( ): Actinomycin-D, N=32

4 Background SAKK 23/82: Tamoxifen improved DFS for ER+ postmastectomy ILRR Disease-free Survival Years since randomization Waeber M et al. Ann Oncol No prospective randomized trial of adjuvant chemotherapy for ILRR has been published in the past 30 years

5 CALOR Trial Eligibility Criteria First ipsilateral local and/or regional recurrence breast (IBTR) chest wall mastectomy scar and/or skin axillary or internal mammary lymph nodes Complete gross excision of recurrence Negative or microscopically involved margins No evidence of supraclavicular lymph nodes No evidence of distant metastasis

6 CALOR Trial S U R G E R Y Strata Prior Chemo-Tx ER+ and/or PR+ Location ILRR R A N D O M I Z E Chemotherapy No chemotherapy + Endocrine therapy for ER+ and/or PR+ + HER2-directed therapy (optional) Chemotherapy chosen by investigators Recommendation: 2 drugs, 3 to 6 months of therapy

7 ILRR Radiation Therapy Radiation therapy Recommended for all patients Mandatory for patients with microscopically involved margins 40 Gy

8 Endpoints 1 endpoint: Disease-free survival 2 endpoint: Overall survival All analyses are by intent to treat

9 Statistical Considerations Original sample size for HR = patients, 347 DFS events Low accrual rate Newer, more effective chemotherapies Amendment 3, 2008: Revised sample size for HR = patients, 124 events 5-year DFS for the observation group: 50% 1-β = 0.8, logrank α = 0.05, 1 interim analysis

10 Statistical Considerations January 31, 2010 Closure of the trial with 162 patients, no interim analysis Analysis plan (April, 2010) analyses to be conducted when the median follow up reaches four years with a minimum follow up of 2.5 years

11 CALOR International Collaboration Participants BIG 89 IBCSG 57 Individual Centers (Hungary, South Africa, Peru) 39 SAKK (Switzerland) 16 ANZ BCTG (Australia) 2 GEICAM (Spain) 20 BOOG (The Netherlands) 12 NSABP 73 TOTAL PARTICIPATION 162

12 Baseline Characteristics No Chemotherapy N=85 Chemotherapy N=77 Primary surgery: Mastectomy 39% 40% Breast conserving Sx 61% 60% Prior Chemotherapy 58% 68% Median time from primary to 5 (0.3-32) 6 (0.4-22) surgery for ILRR (years, range) Menopausal Status at ILRR Premenopausal 24% 18% Postmenopausal 76% 82% Median age at ILRR (range, years) 56 (38-71) 56 (31-82)

13 Baseline Characteristics Chemotherapy N=85 No Chemotherapy N=77 Location of ILRR Breast 55% 53% Mx scar/chest wall 32% 34% Regional lymph nodes 13% 13% ER Status of the ILRR Positive 66% 62% PgR Status of the ILRR Positive 52% 45%

14 Therapies for ILRR No Chemotherapy N=85 Chemotherapy N=77 Radiation therapy 44% 39% Hormonal therapies LHRH agonist or oophorectomy 6% 13% Fulvestrant 1% Tamoxifen 18% 18% Aromatase inhibitors 55% 53% Endocrine treatment for ER+ ILRR 91% 92%

15 Therapies for ILRR No Chemotherapy N=85 Chemotherapy N=77 HER2-directed therapies 7% 5% Chemotherapy Monotherapy 31% Docetaxel or Paclitaxel 20% Capecitabine 11% Polychemotherapy 69% Anthracycline-based 48% Anthracycline+taxane-based 1% Taxane-based 16%

16 RESULTS This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute.

17 CALOR Trial Disease-free Survival

18 Sites of First Failure after ILRR Chemotherapy N=85 No Chemotherapy N=77 Failures Local / Regional 6 9 Distant Soft tissue 0 2 Bone 8 5 Viscera 7 15 Contralateral breast 1 1 2nd non-breast malignancy 1 0 Deaths without failure 1 2

19 DFS ER Status ER+ ER- Univariate Interaction term: Treatment x ER: P = 0.044

20 Multivariate Analysis of DFS Hazard P-value Ratio ER (ER+/ ER-) Location of ILRR Breast (reference group) Mastectomy scar or chest wall Lymph nodes Prior chemo (yes/no) Interval from primary surgery (per yr) Treatment (chemotherapy/none) Interaction term: Treatment x ER in ILRR: P = 0.05

21 CALOR Trial Overall Survival

22 OS by ER Status ER+ ER-

23 Multivariate Analysis of OS Hazard P-value Ratio ER (ER+/ ER-) Location of ILRR Breast (reference group) Mastectomy scar or chest wall Lymph nodes Prior chemo (yes/no) Interval from primary surgery (per yr) Treatment (chemotherapy/none)

24 CALOR Trial Conclusions Adjuvant chemotherapy reduced the risk of DFS events by 41% (ER+ 6%; ER- 68%) Death by 59% (ER+ 60%; ER- 57%) Adjuvant chemotherapy should be recommended for patients with completely resected isolated local or regional recurrence of breast cancer The data are strongest for patients with ER-negative recurrences Longer follow-up is needed for patients with ER-positive recurrences

25 CALOR Trial Additional Data The pattern of locoregional recurrences and the impact of chemotherapy on second ILRR will be presented in Poster P , Session 6, December 8, 2012.

26 Thank you Patients who participated in CALOR CALOR surgeons and physicians, trial coordinators, nurses and staff BOOG, GEICAM, IBCSG, NSABP, SAKK John Bryant, PhD

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