1. WSG-ADAPT TN: Neoadjuvant Albumin-Bound Paclitaxel + Carboplatin or Gemcitabine in TNBC
CCO Independent Conference Coverage*: The 2015 Annual Meeting of the CTRC-AACR San Antonio Breast Cancer Symposium, December 8-12, 2015
San Antonio, Texas
*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.
TNBC, triple-negative breast cancer.
This program is supported by educational grants from Genentech and Novartis.

2. WSG-ADAPT TN: Background
pCR predicts improved outcomes in TNBC[1]
Optimal therapy for TNBC not established
Albumin-bound paclitaxel:
Increased pCR rate vs paclitaxel in pts with early BC, particularly TNBC (OR: 2.69)[2]
When combined with gemcitabine increased OS vs gemcitabine in metastatic pancreatic cancer[3]
When combined with carboplatin increased ORR vs paclitaxel + carboplatin in advanced NSCLC[4]
Current report assessed efficacy and safety of albumin-bound paclitaxel + either gemcitabine or carboplatin as neoadjuvant therapy in TNBC[5]
BC, breast cancer; NSCLC, non-small-cell lung cancer; OR, odds ratio; pCR, pathological complete response; TNBC, triple-negative breast cancer.
1. Cortazar P, et al. Lancet. 2014;384: Untch M, et al. SABCS Abstract S Von Hoff DD, et al. N Engl J Med. 2013;369: Socinski MA, et al. J Clin Oncol. 2012;30: Gluz O, et al. SABCS Abstract S6-07.
Slide credit: clinicaloptions.com

3. WSG-ADAPT TN: Study Design
Biopsy at
Baseline and Wk 3
Wk 12
Albumin-Bound Paclitaxel 125 mg/m2 +
Gemcitabine 1000 mg/m2*
(n = 182)
Surgery or
biopsy†
Pts with TNBC, no distant metastasis, LVEF ≥ 50% or within normal limits
(N = 336)
Albumin-Bound Paclitaxel 125 mg/m2
+ Carboplatin AUC2*
(n = 154)
AUC, area under the curve; EC, epirubicin, cyclophosphamide; EFS, event-free survival; LVEF, left ventricular ejection fraction; pCR, pathologic complete response; TNBC, triple-negative breast cancer.
*Treatment given in 4 cycles in both arms at Wks 1, 2, 4, 5, 7, 8, 10, 11.
†Standard chemotherapy (4 x EC) recommended after surgery or 12-wk biopsy (if clinical non-pCR).
Primary endpoint: pCR (ypT0/is ypN0)
Secondary endpoints: pCR by early response, EFS, OS, safety
Slide credit: clinicaloptions.com
Gluz O, et al. SABCS Abstract S6-07.

4. WSG-ADAPT TN: Baseline Characteristics
Albumin-Bound Paclitaxel + Gemcitabine
(n = 182)
Albumin-Bound Paclitaxel + Carboplatin
(n = 154)
Median age, yrs (range)
50 (26-75)
52 (29-76)
cT, % 1
≥ 2
37.4
62.6
37.0
62.9
cN, %
≥ 1
74.2
25.8
73.4
26.6
Median Ki67, % 75 70
Central grade 3, %
94.5
90.9
Slide credit: clinicaloptions.com
Gluz O, et al. SABCS Abstract S6-07.

5. WSG-ADAPT TN: pCR
Albumin-bound paclitaxel + carboplatin significantly increased pCR vs albumin-bound paclitaxel + gemcitabine
Consistent benefit across cT, Ki67, and menopausal subgroups
pCR more likely in pts with an early response (44.4% vs 19.5%; P < .001)
This effect seen regardless of treatment arm
pCR, n/N (%)
Albumin-Bound Paclitaxel + Gemcitabine
Albumin-Bound Paclitaxel + Carboplatin
P Value
All pts
51/178 (28.7)
67/146 (45.9)
< .001
Pts with early response
26/72 (36.1)
38/72 (52.8) NR
Pts without early response
10/74 (13.5)
13/44 (29.5)
NR, not reported; pCR, pathologic complete response.
Slide credit: clinicaloptions.com
Gluz O, et al. SABCS Abstract S6-07.

6. WSG-ADAPT TN: Safety
Dose reduction more frequent with albumin-bound paclitaxel + gemcitabine vs albumin-bound paclitaxel + carboplatin (20.6% vs 11.9%, respectively)
Fewer serious AEs, CTC grade ≥ 3 with albumin-bound paclitaxel + carboplatin
AEs, %
Albumin-Bound Paclitaxel + Gemcitabine
(n = 182)
Albumin-Bound Paclitaxel + Carboplatin
(n = 154)
Serious AEs
17.2
10.6
Treatment-related serious AEs
5.3
CTC grade ≥ 3
Neutropenia
Febrile neutropenia
Infections
Increased ALT
Polyneuropathy
15.0
6.1
11.7
0.6
14.6
0.7
1.3
3.3
AE, adverse event; ALT, alanine aminotransferase; CTC, common toxicity criteria.
Slide credit: clinicaloptions.com
Gluz O, et al. SABCS Abstract S6-07.

7. WSG-ADAPT TN: Conclusions
12 wks of albumin-bound paclitaxel + carboplatin significantly increased pCR vs albumin-bound paclitaxel + gemcitabine in pts with TNBC
pCR more likely in pts with early response at Wk 3 biopsy regardless of study treatment
Fewer serious AEs, CTC grade ≥ 3, with albumin- bound paclitaxel + carboplatin
AE, adverse event; CTC, common toxicity criteria; pCR, pathologic complete response; TNBC, triple-negative breast cancer.
Slide credit: clinicaloptions.com
Gluz O, et al. SABCS Abstract S6-07.

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