Annual Meeting Proceedings Part 1 - American Society of Clinical ...

28s Breast Cancer—HER2/ER
586 General Poster Session (Board #7E), Sat, 8:00 AM-12:00 PM
Relapse rate after adjuvant trastuzumab in the northeast of Italy: Preliminary
data from a multicenter observational study in a clinical setting.
Presenting Author: Giorgio Mustacchi, UOC Centro Oncologico, ASS1 Friuli
Venezia Giulia/Università, Trieste, Italy
Background: Relapse Rate (RR) after adjuvant trastuzumab (AT) reported in
clinical trials is between 15 and 21%. Information on RR and clinical
behaviour of HER2-POS metastatic disease after AT outside clinical trials
is limited. At ASCO Meeting 2010 RR was reported 8% (Abs 1080) to 10%
(Abs 684), with a Survival Post Progression (SPP) of 8.8 and 5.7 months,
respectively. It is useful to increase informations about metastatic HER2-
POS disease after AT, outside clinical trials. Methods: HER2-POS consecutive
cases treated with AT in 6 Hospitals of North East Italy were
anonymously collected and merged. The following data were analyzed:
Stage, ER/PgR Status, Chemotherapy regimens (CHT) , follow up, RR,
Disease Free Survival (DFS), Overall Survival (OS) and SPP. Results: The
number of patients was 413, median age 55 (24-84). Anatomic Stage was I
in 39.7%, II in 40,3%, III in 24.4%. ER/PgR neg cases were 164 (41.6%).
Given CHT were Anthra-based 33.4% and Anthra-Taxane 54.5%. At a
mean follow up of 35 months (7-115) RR was 10.8% (45 cases), with a
mean DFS of 23.8 months (3.2-74). Among relapsed patients, 37/45
(82.2%) had ER/PgR neg tumors. One patient died NED for CHF and 22 for
metastatic disease, with a mean OS of 37.1 months (10.2-87.9). Mean
SPP was 17.8 months. According to DFS �12 mos , �12�24 and �24,
mean OS was 31.3, 31.7 and 56.12(p�0.03) months; SPP was 24.2,
14.4 and 17.8 months, respectively. Conclusions: In our experience RR
after AT is lower than in published Phase III clinical trials. ER/PgR neg
status seems a negative prognostic factor (82.2% in the relapsed population
vs 41.6% overall). OS is similar for patients relapsed within 24 months
but SPP is 10 months longer in very early relapses. Relapse after 2 years is
correlated with a long OS (nearly 5 years), with SPP shorter vs early relapse
(17.8 vs 24.2 months). Our preliminary results suggest different disease
behaviors in relapsed HER2-POS Breast Cancer after AT, with different
DFS and SPP, suggesting a different effect of further therapies. Considering
the small RR, the study target accrual is proceeding to collect up to
more than 1000 AT treated patients, including post-progression treatments,
not available at the moment.
588 General Poster Session (Board #7G), Sat, 8:00 AM-12:00 PM
A multicenter phase II trial of the LH-RH analogue and an aromatase
inhibitor combination in premenopausal patients with advanced or recurrent
breast cancer refractory to an LH-RH analogue with tamoxifen: JMTO
BC08-01. Presenting Author: Reiki Nishimura, Kumamoto City Hospital,
Kumamoto, Japan
Background: The aim was to provide an endocrine therapy option against
advanced (ABC) or recurrent breast cancer (RBC) in premenopausal
women. We conducted an exploratory phase II trial in combination with an
LH-RH analogue (LH-RHa) and an aromatase inhibitor (AI) to assess the
efficacy and tolerability after failure of standard LH-RHa plus tamoxifen
(TAM). Methods: Premenopausal patients (pts) with ER� and/or PgR� ABC
or RBC refractory to LH-RHa � TAM were treated with LH-RHa (goserelin:
GOS) and AI (anastrozole: ANA). The primary endpoint was an objective
response rate (ORR). Secondary endpoints included progression-free survival
(PFS), overall survival (OS), clinical benefit rate (CBR) based on
RECIST, and safety assessed using CTCAE ver. 3.0. Pts with only bone
legions were assessed using the criteria by Japanese Breast Cancer Society
(14th Ed.). Local assessment (CR, PR or long SD of 24 weeks or longer) was
confirmed independently by two radiologists. Results: Between September
2008 and November 2010, 37 pts were enrolled at 10 clinical institutions
in Japan. Eleven had recurrence either during, or within one year after the
end of adjuvant GOS � TAM (including GOS � TAM followed by only TAM).
The disease progressed in 26 women during GOS � TAM. Mean age and
BMI were 43.5 years and 22.2 kg/m2, respectively. Thirty-five pts (94.6%)
were ER�, and 36 pts (97.3%) were HER2- (one with unknown HER2
status). Non-endocrine treatment included chemotherapy (20 pts; 54%)
and radiation therapy (13 pts; 35%). The viscera, soft tissue, and bones
were treated in 17, 15 and 14 pts, respectively. Pts with both measurable
lesions and bone metastasis, measurable lesions only, and only bone
metastasis were 21 (57%), 15 (41%) and 1 (2%), respectively. ORR was
18.9% (95%CI: 8.0-35.2%, 1 CR and 6 PR cases), CBR 62.2% (23 pts,
95%CI: 44.8-77.5%), and median PFS was 7.2 months. Eight pts
(21.6%) had adverse events, but none resulted in treatment discontinuation.
GOS � ANA was well tolerated. Conclusions: LH-RHa (GOS) � ANA
can be a subsequent endocrine treatment for premenopausal pts with ABC
or RBC after failure of GOS � TAM.
587 General Poster Session (Board #7F), Sat, 8:00 AM-12:00 PM
Endocrine therapy in early breast cancer: Encouraging observations in a
nontrial setting. Presenting Author: Susan Faye Dent, The Ottawa Hospital
Cancer Centre, Ottawa, ON, Canada
Background: Poor adherence to adjuvant endocrine therapy (ET) in women
with hormone receptor positive (HR �) early breast cancer (EBC) is well
documented. Given the availability of multiple ET strategies [aromatase
inhibitor (AI) upfront, tamoxifen (TAM) to AI, AI after 5 years TAM], we
evaluated the delivery of ET in a non-trial setting. Methods: Postmenopausal
women with HR � EBC treated with ET (that included an AI) at
The Ottawa Hospital Cancer Center between 01/99 and 12/06 were
included. Data was retrospectively collected and included: demographics,
choice/duration of ET, adherence and toxicities. Results: In 626 patients
(pts), median age 59 years (r: 30-92) with stage I (195 pts; 31 %), stage II
(339 pts; 54 %) and stage III (88 pts; 14 %) EBC. Treatment strategies
included: AI (s) only (251 pts; 40 %); TAM followed by AI (s) (323 pts;
51.6 %); AI (s) followed by TAM (16 pts; 2.6 %); TAM-AI (s)-TAM (24 pts;
3.8 %) and unknown (12 pts; 1.9 %). Prescribed AI therapy (upfront or
sequential) was discontinued in 39 % of cases mainly due to toxicity (62.5
%) after median of 6, 9, or 12 months (ms) on exemestane, anastrazole and
letrozole respectively. Common toxicities included: arthralgias (40.6 %),
hot flushes (34 %), fatigue (25 %), myalgias (24.7 %) and osteoporosis
(22.5%). In cases (177) where AI therapy was discontinued due to toxicity:
98 received no further ET, 29 TAM and 50 another AI. The majority of pts
received at least 5 years of ET (79 %; median duration 64 ms; r 1-156 ms)
and 376 pts (60 %) completed at least 5 years of AI therapy (median
duration 59 ms; r: 1-124 ms). 9.9 % of pts are still receiving ET.
Conclusions: This is one of the first non-clinical trial studies to demonstrate,
that despite poor adherence to initial ET, the majority of women are able to
complete five years of treatment (79 %). These results are encouraging and
reflect the practical use of mutilple endorcrine strategies that have been
shown to be efficacious in this pt population.
589 General Poster Session (Board #7H), Sat, 8:00 AM-12:00 PM
Multiple chemotherapy (CT) lines in metastatic breast cancer (MBC):
Which survival benefit for women with hormone receptor (HR)-positive
disease? Presenting Author: Raffaella Palumbo, Fondazione Maugeri-
IRCCS, Pavia, Italy
Background: Although the development of modern systemic therapies has
clearly improved outcome of patients with MBC, the true impact of further
CT on overall survival (OS) and QoL of these women is still debated. The aim
of this study was to determine which benefit could be brought by successive
CT lines in patients with HR-positive disease, aiming to identify factors
affecting outcome and survival. Methods: This retrospective analysis
included 980 women treated with CT for MBC at our Institution over a eight
year period (July 2000-July 2008). With OS data updated in March 2010,
the median follow-up was 146 months (range 48-198), OS and time to
treatment failure (TTF) were calculated according to the Kaplan-Meyer
method for each CT line. Cox proportional hazards model was used to
identify factors that could influence TTF and OS. Results: Median OS
evaluated from day 1 of each CT line decreased with the line number from
34.8 months for first line to 8.2 months for 7 or more lines). Median TTF
ranged from 9.2 months to 7.8 and 6.4 months for the first, second and
third line, respectively, with no significant decrease observed beyond the
third line (median 5.2 months, range 4.8-6.2). No statistically significant
difference was found between HR-positive and HR-negative patients in
terms of OS and TTF by each CT line. In univariate analysis factors
positively linked to a longer duration of TTF for each CT line were positive
hormonal receptor status, more than 3 hormonotherapy lines, absence of
liver metastasis, adjuvant CT exposure, response to CT for the metastatic
disease; in the multivariate analysis the duration of TTF for each CT line
was the only one factor with significant impact on survival benefit for
subsequent treatments, in both HR-positive and negative populations
(p�0.001). Conclusions: Our results support the benefit of multiple lines of
CT in a significant subset of women treated for MBC, since each CT line
may contribute to a longer OS. Of interest, such a benefit was also observed
for patients with HR-positive disease, although the number of hormonotherpy
lines received did not significantly influence the outcome.
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