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Annals of Oncology
29.2% PRs. Median time to progression (TTP) was 6.1 months (range, 3.2-9.0
months) in group NP and 6.3 months (range, 4.1-8.5 months) in group NX(P =
0.783). COX regression showed no statistically significant difference (P = 0.782, OR =
0.920). Median overall survival (OS) was 28.8 months (range, 21.6-36.0 months) in
group NP and 15.1 months (9.6-20.6 months) in group NX(P = 0.027, OR = 0.495).
COX regression showed a statistically significant difference(P = 0.045). Neutropenia
was the most frequent hematologic toxicity, with 57.9% grade 3/4 neutropenia
observed in group NP and 38.1% in group NX(P = 0.145). 13.2% grade 3/4 vomiting
was seen in group NP and no grade 3/4 vomiting in group NX. No grade 3/4
nephrotoxicity or hand-foot syndrome was noted in both groups.
Conclusion: Better OS was seen in group NP than in group NX. Treatment-related
toxicity in both groups was manageable.
Disclosure: All authors have declared no conflicts of interest.
395 DOCETAXEL (D), GEMCITABINE (G) AND BEVACIZUMAB (BEV)
AS SALVAGE CHEMOTHERAPY (CT) FOR HER-2 NEGATIVE
METASTATIC BREAST CANCER (MBC)
E. Kontopodis 1 , C. Christophylakis 1 , N. Kentepozidis 1 , I. Boukovinas 1 ,
S. Giassas 1 , E. Saloustros 1 , A. Kalykaki 1 , V. Bozionelou 2 , V. Georgoulias 1 ,
D. Mavroudis 1
1 Medical Oncology, Hellenic Oncology Research Group (HORG), Athens,
GREECE, 2 Medical Oncology, University General Hospital of Heraklion, Athens,
GREECE
Introduction: The combination of D and G is a valid salvage CT regimen for the
treatment of mBC. When combined with CT, Bev has increased the response rate and
progression-free survival (PFS) in both first and second line treatment of mBC. In this
multicenter study, we evaluated the combination of D, G, and Bev, administered
biweekly, as second or further line CT in patients (pts) with HER-2 negative mBC.
Methods: Women with HER-2 negative mBC, who had received at least one prior
line of CT, were treated with D 50 mg/m2, G 1500 mg/m2 and Bev 10 mg/Kg, in
cycles every two weeks. Bev was continued until disease progression. This was a
study with Simon’s optimal two step statistical design.
Results: Forty-eight pts have been enrolled. Median age was 61 years, performance
status was 0-1 in 95.8% and 2 in 4.2% of pts, 83.3% had hormone receptor positive
disease, and 47.9% had received one prior line of CT. All pts were evaluable for
toxicity and 43 for response. Objective response rate was 44.2% (95% confidence
interval [CI], 29.3-59%), median PFS was 6.8 months (95% CI, 4.5-9.1 months), and
median overall survival 20.1 months (95% CI, 9.9-30.3 months). Grade 3-4
hematologic toxicity consisted of neutropenia (39.6%) and febrile neutropenia
(4.2%). Most common grade 2-3 non-hematologic adverse events included nausea
(10.4%), diarrhea (10.5%), neurotoxicity (12.5%), fatigue (31.3%), allergic reactions
(6.3%), hemorrhage (4.2%), and hypertension (4.2%). No grade 4 non-hematologic
toxicities or toxic deaths were recorded.
Conclusion: The combination of D, G and Bev has promising activity and a
manageable toxicity profile as salvage CT for HER-2 negative mBC. Updated results
will be presented at the congress.
Disclosure: All authors have declared no conflicts of interest.
396 EFFICACY OF TRASTUZUMAB CONTAINING RETREATMENT
AFTER PROGRESSION ON LAPATINIB THERAPY IN JAPANESE
PATIENTS WITH HER2-POSITIVE METASTATIC BREAST
CANCER
M. Hattori 1 ,H.Iwata 1 , T. Fujita 1 , M. Sawaki 1 , N. Kondo 1 , A. Horio 1 , K. Muro 2
1 Breast Oncology, Aichi Cancer Center, Nagoya, JAPAN, 2 Clinical Oncology,
Aichi Cancer Center Hospital, Nagoya, JAPAN
Background: Lapatinib has been approved for HER2 positive metastatic breast cancer
patients with refractory to trastuzumab (T) therapy in Japan. Currently, it has been
proposed that lapatinib can resensitize trastuzumab–mediated antibody-dependent
cellular cytotoxicity (ADCC). Recent clinical data suggest the efficacy of T containing
retreatment after progression on lapatinib therapy in patients with HER2-positive
metastatic breast cancer. Here, we present a retrospective review of data from 25
patients who received T containing retreatment after progression on lapatinib therapy.
Methods: We reviewed the data of 50 patients with HER2-positive metastatic breast
cancer who received lapatinib therapy in our institution from August 2004 through
March 2012. Of these, 25 patients received T containing retreatment after
progression on lapatinib therapy. We retrospectively assessed the clinical benefit of
this treatment regimen in these patients.
Results: Luminal-HER2 and HER2-enriched subtypes were identified in 13 (52%)
and 12 (48%) of these cases, respectively. The median duration of lapatinib therapy
was 5.9 months (range, 1.8-20.2 months). The median number of preceding
regimens was 3 (range, 2-8) in metastatic setting. Seven patients (31.8%) responded
to T containing retreatment; all 7 patients achieved PR and none achieved CR. There
were no significant differences in subtype, number of preceding regimens and brain
metastases; however, responders achieved higher clinical response from lapatinib
therapy than non-responders (response rate of 84% versus 13%, respectively). The
median time to progression of T containing retreatment was 3.0 months (95% CI,
2.4-3.5 months). Among seven responders to T containing retreatment, one patient
responded to refractory T containing regimen. All patients tolerated T containing
retreatment with no occurrence of Grade 3/4 toxicities.
Conclusion: T containing retreatment could be a favorable treatment regimen which
can achieve clinical response in patients with HER2-positive metastatic breast cancer
who experienced progression on prior trastuzumab and following lapatinib therapy.
Disclosure: All authors have declared no conflicts of interest.
397 LOW DOSES OF GEMCITABINE (G) WITH CISPLATIN (C)
IN TREATMENT OF METASTATIC BREAST CANCER (MBC)
PROGRESSING AFTER ANTHRACYCLINES, TAXANES,
CAPECITABINE AND OTHER ANTINEOPLASTIC AGENTS
T.Y. Semiglazova 1 , M.L. Gershanovich 1 , D.H. Latipova 1 , L.V. Filatova 1 ,V.
A. Chubenko 1 , V.F. Semiglazov 2 , V.V. Semiglazov 3 , P.V. Krivorotko 2 ,D.
E. Matsko 4 , V.V. Klimenko 3
1 Department of Chemotherapy, N.N.Petrov Research Inst. of Oncology,
St. Petersburg, RUSSIAN FEDERATION, 2 Breast Cancer Department, N.N.
Petrov Research Inst. of Oncology, St. Petersburg, RUSSIAN FEDERATION,
3 Department of Oncology, Pavlov Medical University, St. Petersburg, RUSSIAN
FEDERATION, 4 Department of Pathology, N.N.Petrov Research Inst. of
Oncology, St. Petersburg, RUSSIAN FEDERATION
Background: The highest synergism of G was registered with C, as G suppresses DNA
reparation after its damage from C, which leads to apoptosis of tumor cell. The study of
optimal doses of G and C combination continues for intensive pretreated MBC.
Purpose: Evaluate efficiency and tolerability of the low doses of G and C in 131
patients with MBC progressing after anthracyclines, taxanes, capecitabine and other
antineoplastic agents.
Methods: G 600-750 mg/m 2 and C 30 mg/m 2 were administered on days 1 and 8
every 3 weeks in the 2 nd line for 28 patients, in the 3 rd for 54 patients and in the 4 th
for 49 patients. Groups were comparable in age, performance status (PS), ER/PgR
and HER2 expressions, localization and number of metastatic sites prior to
treatment.
Results: Total amount of cycles: 549, median 4.2 per patient (range: 2-12). The
overall response (OR) of all patients was 27%, clinical benefit (OR + stable disease) –
71.7%, with median time to progression (TTP) 4.8 months (95% CI 3.9-5.7 months)
and median overall survival (OS) 14.6 months (95% CI 12.1-17.1 months). The OR
in the 2 nd line was observed in 39.3%, in the 3 rd – 27.8% and in the 4 th – 18.4% (р <
0.05), clinical benefit – in 85.7, 59.3 and 77.6% (р > 0.05) respectively. Pain intensity
reduction and improvement of PS were noted in patients in spite of the lines. Linear
discriminant and regression analyses showed that OR, TTP and OS didn’t depend on
the ER/PgR and HER2 expressions, but ECOG 2-3, pain syndrome, metastases in the
lymph nodes and liver were the factors of poor prognosis. The treatment-related
adverse events were neutropenia, anemia, thrombocytopenia, alopecia, nausea,
vomiting, peripheral neuropathy and fatigue. Toxicities with grade 3-4 intensity were
neutropenia (31.6% of patients), vomiting (0.8%), anemia (2.3%), thrombocytopenia
(3.1%). No febrile neutropenia and deaths related to the study treatment occurred.
Conclusions: The low doses of G with C are effective and tolerable in treatment of
MBC progressing after antracycline, taxanes, capecitabine, other antineoplastic agents not
only in the 2 nd and 3 rd ,butalsointhe4 th lines and are suitable for outpatient therapy.
Disclosure: All authors have declared no conflicts of interest.
398 LONG TERM USE OF CAPECITABINE IN PATIENTS WITH
LOCALLY RECURRENT OR METASTATIC BREAST CANCER
D.H. Josephs 1 , R. Mir 2 , T. Siow 1 , L.E. Dumas 1 , V. Michalarea 1 , E. Sawyer 2 ,J.
L. Mansi 1
1 Medical Oncology Offices, 4th Floor Bermondsey Wing, Guys Hospital, Guys
and St Thomas’s NHS Trust, London, UNITED KINGDOM, 2 Clinical Oncology,
Guy’s and St Thomas’ NHS Trust, London, UNITED KINGDOM
Background: Capecitabine monotherapy is considered standard treatment in
anthracycline- and taxane-pretreated locally recurrent or metastatic breast cancer and
has proven efficacy in this setting. Here we report the findings of a retrospective
study to evaluate the impact of continuing capecitabine treatment beyond the
standard 6 cycles until disease progression, on efficacy and outcomes in patients with
locally recurrent or metastatic breast cancer. In addition we sought to consolidate the
information known about capecitabine dose modification and efficacy outcomes in
this patient population.
Patients and methods: Clinical databases in two institutions were used to identify all
patients with locally advanced or metastatic breast cancer treated with capecitabine
over the period July 2006 – July 2011. Baseline characteristics, progression-free (PFS)
and overall survival (OS) were recorded.
Results: In total, 150 patients met the inclusion criteria. Of these patients 67 (45%)
received less than 6 cycles, 17 (11%) received 6 cycles only and 66 (44%) received
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