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Results: We evaluated 76 pts with MTNBC after 4 cycles of PCMF chemotherapy.
CR was found in 3 pts (3.9%), PR in 16 pts (21.0%), SD in 11 pts (14.5%), and PD
in 39 pts (51.3%); with ORR in 19 pts (24.9%) and TCR in 30 pts (39.5%).
Hematological toxicity: grade 3 and 4 anemia was found in 4 pts (5.3%) and
leukopenia in 9 pts (11.8%). Non-hematological toxicity: renal grade 3 awas observed
in 2 pts (2.6%). Not a single therapy was interrupted due to toxicity, but therapy
prolongation was present in 15% of applied cycles.
Conclusions: The application of PCMF chemotherapy q4w in the treatment of
patients previously treated with anthracyclines and taxanes as adjuvant treatment
appeared to be effective with ORR in 24.9% and TCR in 39.5% and can be
administered with good tolerance.It is today our standard treatment in this pts
population.
Disclosure: All authors have declared no conflicts of interest.
391 TRASTUZUMAB-BASED CHEMOTHERAPY (CT) FOR
HER2-POSITIVE METASTATIC BREAST CANCER (MBC): WHICH
OPTIMAL PARTNER BEYOND THE FIRST LINE? A
SINGLE-CENTRE RETROSPECTIVE STUDY
R. Palumbo 1 , A. Bernardo 1 , A. Riccardi 2 , F. Sottotetti 1 , M. Azzarà 2 ,
B. Tagliaferri 1 , E. Pozzi 1 , C.M. Teragni 1 , G. Bernardo 1
1 Oncologia Medica 2, Fondazione S. Maugeri IRCCS, Pavia, ITALY, 2 Medical
Oncology, University of Pavia, Pavia, ITALY
Background: The activity of trastuzumab-based chemotherapy (CT) in HER2+ MBC
is well established, but the question of the optimal CT partner remains a relevant
issue. We performed a retrospective comparison of the clinical outcomes associated
with different trastuzumab-CT regimens.
Patients and methods: Patients (pts) for this analysis were selected from a
monoinstitutional database of HER2+ MBC pts receiving trastuzumab-based CT for
the metastatic disease (February 2005-December 2008). Treatment activity and safety
were assessed by the WHO criteria, time to progression (TTP) and overall survival
(OS) were calculated by the Kaplan Meier method.
Results: A total of 147 pts with measurable disease were evaluated: 57 received
trastuzumab with weekly vinorelbine (T/VNR), 48 weekly or 3–weekly trastuzumab
plus docetaxel (T/Doc), 42 a triple combination of 3-weekly trastuzumab plus oral
vinorelbine and capecitabine (T/osVNR/Cape) as 1 st line therapy. Objective RR was
76% in the T/VNR group, 68% in the T/Doc regimen, and 72% in the T/osVNR/
Cape combination. There was no significant difference in median TTP according to
treatment type (14, 11 and 12 months, respectively, p = 0.62); median OS was 36
months, 32 and 34 months, respectively (p = 0.48). More treatment-related grade 3-4
toxicities were recorded in the T/Doc population. Following progression, pts received
trastuzumab-based subsequent lines of treatment; according to our Institution police,
shifting to a different CT partner: all had a 2 nd line, 86 a 3 rd line, 41 a 4 th line, 7 a
5 th line. In univariate analysis no visceral involvement, T/Doc 1 st line CT, low
primary tumor grading were correlated with better PFS and OS; in multivariate
analysis the number of trastuzumab-based regimens was the only factor with
statistically significant impact on OS (p = 0.02).
Conclusions: These results confirm the high activity of the tested regimens as 1 st
line therapy of HER2+ MBC, without significant differences in clinical outcomes,
also suggesting the benefit of multiple lines of trastuzumab-based CT in a
significant subset of pts, since each subsequent line may contribute to a longer
OS.
Disclosure: All authors have declared no conflicts of interest.
392 PHASE II STUDY OF SINGLE AGENT ORAL VINORELBINE (OV)
AS FIRST-LINE CHEMOTHERAPY (CT) IN PATIENTS (PTS) WITH
HER-2 NEGATIVE METASTATIC BREAST CANCER (MBC): A
SINGLE CENTER EXPERIENCE
M. Mansour 1 , C. Mourad 2
1 Oncology, Erfan Hospital, Jeddah, SAUDI ARABIA, 2 Medical Affairs, Pierre
Fabre Medicament, Beirut, LEBANON
Background: Quality of life and pts’ preferences play an important role in treatment
decision-making in the metastatic setting. Previous studies indicated that Oral CT is
convenient and a preferred option by many pts. We hereby report the efficacy and
safety of OV as first-line CT for MBC.
Patients and methods: 31 pts were enrolled between January 2007 and December
2010. All pts had measurable disease, a majority (84%) relapsing after anthracyclines
(ANT) and/or taxanes (TXN) adjuvant treatment, WHO PS ≤ 2, adequate bone
marrow, hepatic and renal functions and no adjuvant CT within the last 6 months.
Pts were treated every 3 weeks with OV 60 mg/m 2 D1 and D8 for the 1 st cycle and
thereafter 80 mg/m 2 D1 and D8 every 3 weeks in the absence of G4 neutropenia
and/or febrile neutropenia. Treatment was administered until disease progression or
unexpected adverse event or pt refusal to continue. Primary endpoint (EP) was
Objective Response Rate (ORR); secondary EPs were TTP, OS and safety. Follow-up
results until April 2012 are reported.
Results: Median age was 42 years (range, 33 -75); median WHO PS 1 (range, 0-2).
Previous adjuvant therapy: ANT-based alone: 29%, TXN-based alone: 19%, ANT plus
TXN: 36%, other: 16%. Median disease-free interval from end of previous CT was 7
months. 26 pts (84%) had 2 or more metastatic sites, liver (61%), bone (58%), lung
(58%) being the most frequent sites. A median of 6 cycles were administered (range,
2-20). ORR was achieved in 9 pts (29%), including 1 complete and 8 partial responses.
12 pts (39%) had stable disease, resulting in a clinical benefit rate (CBR) of 68%. In pts
pretreated by ANT, ORR was 35% and CBR was 70%. Median TTP was 3.7 months
[95% CI: 2.2-5.2]. Median survival was 16 months [95% CI: 11.4-20.6]. 3 pts (10%)
developed G 3-4 neutropenia. No events of febrile neutropenia, cardiac, renal toxicities
or alopecia were recorded. G 3 thrombocytopenia was reported in 2 pts (6%). 5 pts
(16%) developed G 3 nausea-vomiting.
Conclusions: Results show a good efficacy and tolerance profile of OV as first line CT
for HER-2 negative MBC pts. Similar activity was observed in the sub-group of pts
pretreated by ANT.
Disclosure: All authors have declared no conflicts of interest.
393 VINORELBINE WITH OR WITHOUT TRASTUZUMAB
IN METASTATIC BREAST CANCER
Annals of Oncology
A. Stravodimou, K. Zaman, I.A. Voutsadakis
Centre Pluridisciplinaire d’Oncologie, Centre Hospitalier Universitaire Vaudois -
CHUV, Lausanne, SWITZERLAND
Background: Vinorelbine is one of the most widely used drugs in metastatic breast
cancer. We report a single center experience with vinorelbine with or without
trastuzumab in patients with metastatic breast cancer.
Patients and methods: All patients with metastatic breast cancer receiving
vinorelbine with or without trastuzumab during a six years period were
retrospectively reviewed. Demographic data and data on response, time to
progression (TTP) and survival were collected. Patients received vinorelbine IV
25-30 mg/m2or PO 60-80 mg/m2 in days 1 and 8 of a 21 days cycle. In patients who
received concomitant trastuzumab a standard dosing schedule with 8 mg/kg loading
dose followed by 6 mg/kg in subsequent administrations every three weeks was used.
Results: Eighty seven women were included. The median age was 63 years (range 32
to 85). Sixty two patients received vinorelbine alone and 25 patients received
vinorelbine with trastuzumab. In 67 patients this was the first line treatment for
metastatic disease and in 20 patients it was 2nd or later line of treatment. Seventy
patients were evaluable for response while the remaining seventeen patients were not
evaluable due to early progression (n = 6) or early termination of treatment for
adversary effects (n = 11). The response rate of evaluable patients was 37.1% [1.4%
Complete Response (CR) and 35.7% Partial Response (PR)]. Eighteen additional
patients (25.7%) had Stable Disease (SD) for three or more months resulting in a
Disease Control Rate of 62.8%. Twenty four of 54 (44.4%) patients receiving first line
treatment had a response while in the second and subsequent lines setting two of 16
(12.5%) patients responded (x2 = 9.66, p = 0.001). A response was obtained in 63.6%
of patients receiving concomitant trastuzumab and in 25% of patients receiving
vinorelbine alone (x2 = 13.63, p = 0.0002). The median TTP was six months (range
1-45). Sixty six patients of the cohort have died and the median overall survival was
11.5 months (range 1-83). Adverse effects necessitating interruption of treatment
were observed in 18.5% of patients.
Conclusion: This retrospective study of vinorelbine in metastatic breast cancer
confirms a high disease control rate. Response rate is higher in first line treatment
compared to subsequent lines and with the combination with trastuzumab.
Disclosure: All authors have declared no conflicts of interest.
394 A RETROSPECTIVE STUDY OF CISPLATIN/VINORELBINE
VERSUS CAPECITABINE/VINORELBINE AS SECOND-LINE OR
THIRD-LINE TREATMENT IN ADVANCED BREAST CANCER
Y. Liu 1 , S. Shi 1 ,X.Qu 1 , J. Shi 2 , L. Zhang 2 ,L.Xu 2 , Y. Teng 2
1 Medical Oncology, The First Hospital of China Medical University, Shenyang,
CHINA, 2 Department of Oncology, The First Affiliated Hospital of China Medical
University, Shenyang, CHINA
Purpose: To compare the efficacy and safety of cisplatin or capecitabine, both with
vinorelbine, as second-line or third-line treatment in advanced breast cancer
previously treated with anthracyclines and/or taxanes.
Methods: From June 2004 to November 2011, 62 advanced breast cancer patients
were eligible. Patients (38) enrolled in group NP received VIN 25mg/m 2 on day 1
and 8 combined with Cisplatin 75mg/m 2 on day 1 of a 21-day cycle. Patients (24)
enrolled in group NX received VIN 25mg/m 2 on day 1 and 8 of a 21-day cycle
combined with CAP 1000mg/m 2 twice daily for 14 consecutive days followed by 7
days of rest. Tumor assessment was performed every 2 cycles according to RESIST
criteria. Toxicity was assessed according to National Cancer Institute Common
Toxicity Criteria (version 3.0).
Results: The overall response rate (ORR) in group NP was 47.4%, all were partial
responses (PRs). In group NX, ORR was 33.3% (P = 0.275), with 4.2% CRs and
ix138 | Abstracts Volume 23 | Supplement 9 | September 2012