Abstract PD3-04: Complete pathologic response rate to neoadjuvant chemotherapy increases with increasing HER2 ratio in HER2 over-expressing breast cancer: Analysis of the National cancer database (NCDB)

14590 Background: Gemcitabine and cisplatin (GC) is an active and well tolerated combination in the treatment of metastatic bladder cancer (BC). Studies of neoadjuvant chemotherapy in BC suggest improved survival, especially for patients with complete pathologic response. We have prospectively analyzed the tolerability and efficacy of GC as neoadjuvant treatment of invasive BC. Methods: in this single-institution, one-stage phase II trial, patients (pts) with histologically verified muscle-invasive transitional cell carcinoma received 3 cycles of gemcitabine 1200 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1 prior to surgery. Radiologic response was evaluated with computed tomography and magnetic resonance imaging. Planned accrual was 35 pts. Primary endpoint was clinical and pathological response rate. Results: between Jun 2002 and Mar 2005, 22 pts (19 males) were enrolled. Accrual was poor due to a higher percentage of superficial tumors than expected. Median age was 61 years. All pts had Performance Status 0 or 1. Initial stage was II (T2) in 11 and III (T3–4) in 11 pts. Chemotherapy was well tolerated with infrequent grade III/ IV toxicity (nausea/ vomiting in 27%, neutropenia in 23% and neutropenic fever in 1 patient). Median follow-up is 26 months (6–40). Partial radiologic response rate was documented in 15 out of 19 assessable pts (79%). One patient was excluded due to renal toxicity in the first chemotherapy cycle and other had sarcomatoid carcinoma at definitive pathologic examination. By Dec 2005, 14 pts underwent radical cystectomy, 4 pts pelvic radiotherapy, 1 is waiting surgery and 1 had systemic progression before surgery. Nine out of 20 pts (45%) relapsed (8 systemic and 1 local) and 4 (20%) are dead (3 with confirmed disease progression). Complete pathologic response was observed in 3 pts (21.5% of 14) and local progression during chemotherapy in another 3 pts. Median estimated progression-free survival by Kaplan-Meier is 27 months (CI 95% 20.5–33.5) with median overall survival not reached. Conclusions: the combination of gemcitabine and cisplatin is effective and tolerable when used as neoadjuvant therapy in muscle-invasive bladder cancer. Longer follow-up is necessary to evaluate its impact in the overall survival of these pts. [Table: see text]

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Pathologic response rate (pCR) and near-pathologic response rate (near-pCR) with docetaxel-carboplatin (TCarb) in early triple-negative breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.27_suppl.277 ◽

2011 ◽

Vol 29 (27_suppl) ◽

pp. 277-277 ◽

Cited By ~ 1

Author(s):

P. Kern ◽

H. C. Kolberg ◽

A. Kalisch ◽

C. Liedtke ◽

F. Otterbach ◽

...

Keyword(s):

Breast Cancer ◽

Clin Oncol ◽

Triple Negative Breast Cancer ◽

Triple Negative ◽

Response Rate ◽

Pathological Complete Response ◽

Complete Response ◽

Pathologic Response ◽

Term Survival ◽

Pathologic Response Rate

277 Background: Triple-negative breast cancer (TNBC) is associated with a poor prognosis unless a pathological complete response is achieved (Liedtke C et al. 2008: J Clin Oncol 26:1275-1281) or almost achieved (Symmans WF. 2007: J Clin Oncol 25:4414-4422). Sensitivity to platin compounds has been demonstrated in BRCA1-positive settings (Byrski T et al. 2010: J Clin Oncol 20:28:375-9; Silver DP. 2010: J Clin Oncol 28:1145-1153) with only limited numbers of patients (Byrski T et al. 2010: J Clin Oncol 20:28:375-9) or in sporadic breast cancer with heterogeneous cohorts (Sikov WM et al 2009: J Clin Oncol 27:4693-4700; Chang HR et al. 2010: Cancer 15; 116:4227-4237). Methods: This pivotal trial was to assess the efficacy of platinum and taxane-based combination therapy without the use of anthracyclines. 27 patients with primary TNBC (majority of them cT2, two cT3 and one cT4a) had to be unsuitable for standard anthracycline-based chemotherapy. They received 6 cycles, respectively in two cases only 5 cycles, of carboplatin AUC 6 and docetaxel 75 mg/m2 q3w. The primary endpoint was the pCR-rate, secondary endpoint toxicity. Results: 20 out of 27 (74%) patients had pathological complete response (52%) or near-complete response (22%)—ypT1mic and ypT1a—both being associated with a good prognosis. Seven remaining patients had still good partial response, leaving only low residual cancer burden, which was defined as ypT1. Treatment was well-tolerated: grade III and IV toxicities were neutropenia, thrombopenia, oedema, nausea, joint pain, nail changes, fatigue, hypertension, and alopecia. Conclusions: These results show a high efficacy of carboplatin AUC6 and docetaxel 75 mg/m2 q3w and good feasibility as primary chemotherapy for TNBC with a pCR- and near-pCR-rate of 74% and total response rate of 100%. The incorporation of anthracyclines and parp-inhibitors into further trial designs could enhance the efficacy of these compounds. The omission of exposure to anthracyclines in patients with considerable heart disease risks seems to be feasible with a good pCR-rate, the latter being a surrogate-marker for long-term survival.

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