Randomized trial of sequence vs. combination of capecitabine (X) and docetaxel (T): XT vs. T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 571-571 ◽  
Author(s):  
S. Beslija ◽  
N. Obralic ◽  
H. Basic ◽  
A. Tatarevic ◽  
M. Naila ◽  
...  
Keyword(s):  
Metastatic Breast ◽  
Treatment Rate ◽  
First Line ◽  
First Line Therapy ◽  
Highly Active ◽  
Common Grade ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
Metastatic Sites ◽  
Weekly Cycles

571 Background: Capecitabine (Xeloda [X]) and docetaxel (Taxotere [T]) are highly active single agents in MBC. The XT combination leads to superior overall survival (OS), time to progression (TTP) and response rate (RR) vs. T alone in anthracycline-preatreated MBC [O’Shaughnessy et al. J Clin Oncol 2002], although only one third of pts in the T group received X after progression. We designed this study to determine whether XT is better than sequential T→X in first-line MBC. Methods: 100 pts with measurable MBC, prior adjuvant anthracyclines (100%) but no prior chemotherapy for MBC and KPS ≥70 received 3-weekly cycles of either XT (X 1250mg/m2 bid d1–14 + T 75mg/m2 d1) or T→X (T 100mg/m2 d1 followed after progression by X 1250mg/m2 bid d1–14). X monotherapy data were not considered in the RR or TTP analyses but were included for OS and safety. Results: The XT and T→X arms were well balanced for prognostic factors: median age 48 (29–59) vs. 51 (31–64) years; median KPS 100 (70–100) in both arms; hormone-responsive disease 20 vs. 16%; dominant metastatic sites (liver 42 vs. 44%, lymph nodes 34 vs. 36%, lung 28 vs 24%, bone 20 vs 18%); number of involved organs (1 = 58 vs. 52%, >1 = 42 vs. 48%); median interval since prior adjuvant anthracyclines (18.5 vs. 17.0 months). Efficacy findings are shown in the table . 74% of the pts in the T→X arm crossed-over to X on progression. The post-study treatment rate was similar in both arms. The most common grade 3/4 adverse events (>5% of pts) with XT vs. T→X were: hand-foot syndrome 18 vs. 4%; stomatitis 16 vs. 8%; neutropenia 12 vs. 14%; neutropenic fever 12 vs. 14%; diarrhea 12 vs. 8%; fatigue 8 vs. 12%; alopecia 6 vs. 8%; edema 4 vs. 8%. Dose reductions were necessary for 52% of pts on XT and 36% of pts on T→X. Conclusions: XT provides significant RR, TTP and OS advantages over T→X. XT should be the standard therapy in fit poor-prognosis pts with aggressive disease. [Table: see text] No significant financial relationships to disclose.

Docetaxel (T) followed by capecitabine (X) as first-line chemotherapy in patients (pts) with metastatic breast cancer (MBC): Preliminary findings from a phase II study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10692-10692
Author(s):  
J. L. Bayo ◽  
M. Lomas ◽  
J. Salvador ◽  
M. Ruiz ◽  
A. Moreno
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Dose Intensity ◽  
First Line ◽  
Recent Trial ◽  
Highly Active ◽  
Grade 3 ◽  
Metastatic Sites ◽  
Ecog Ps

10692 Background: X and T are highly active single agents in MBC. The XT combination leads to superior overall survival (OS), time to progression (TTP) and response rate (RR) vs. T alone in anthracycline-pretreated MBC [O’Shaughnessy et al. J Clin Oncol 2002]. The aim of this trial was to evaluate the efficacy and safety of sequentially administered T then X as first-line treatment in MBC. Methods: Pts ≥ 18 years with previously untreated, HER2neu-negative MBC, ECOG PS ≤ 2, were included in this prospective, multicenter, non-randomized, phase II study. Pts received 3 cycles of T (100mg/m2 d1) followed by 3 cycles of X (1250mg/m2 bid d1–14), every 3 weeks. Results: To date, 38 pts are evaluable for safety and 33 pts for efficacy. Baseline characteristics: median age 54.4 years (range 33–76); PS ≥ 1 50%; 36 (95%) pts had previous (neo)adjuvant anthracyclines, 8 (21%) concomitant with paclitaxel. The most frequent metastatic sites were: bone 47%, nodes 39% and liver 36%. 69% of pts had ≥ 2 metastatic sites. To date, 38 pts have received 3 cycles of T and 33 have also received 3 cycles of X. A total of 195 cycles have been administered: T 108 cycles (median 3, range 1–3); X 87 cycles (median 3, range 1–3). Dose reductions and interruptions for T vs. X were 32 vs. 21% and 21 vs. 21%, respectively. Median relative dose intensity: T 0.97 (range 0.62–1.00), X 0.93 (range 0.26–1.00). T grade 3/4 toxicities (37 evaluable pts): asthenia 19%, mucositis 16%, nausea 13%, febrile neutropenia 11%, rash 5%, diarrhea 5%, infection 3%. X grade 3/4 toxicities (33 evaluable pts): hand-foot syndrome 9%, diarrhea 9%, vomiting 9%, asthenia 6%, nausea 3%, anorexia 3%. In the 33 pts evaluable for efficacy, the RR was 61%, including 4 CRs and 16 PRs. At a median follow-up of 6.1 months, median TTP has not yet been reached. Conclusions: These preliminary results show that the sequential regimen of T followed by X is feasible, effective and well tolerated in first-line MBC, although giving X before T should also be investigated. Findings from a recent trial of XT vs. T followed by X [Beslija et al. ECCO 2005] suggest that XT should be standard in fit poor-prognosis pts with aggressive disease. No significant financial relationships to disclose.

Phase II study of capecitabine (X) in combination with vinorelbine (N) in patients (pts) with pretreated metastatic breast cancer (MBC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10693-10693
Author(s):  
N. Batista ◽  
L. Estevez ◽  
P. Sánchez-Rovira ◽  
A. Velasco ◽  
M. Dómine ◽  
...  
Keyword(s):  
Phase Ii ◽  
Metastatic Breast ◽  
Dose Intensity ◽  
Clinical Activity ◽  
Common Grade ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
Few Data ◽  
Metastatic Sites ◽  
Taxane Chemotherapy

10693 Background: X monotherapy is consistently effective and very well tolerated in pretreated MBC. N is also commonly used in this indication. In several studies, the combination of X + N led to response rates ranging from 43–67% in first-line MBC. As there are few data on the combination in pts with pretreated MBC, we evaluated the efficacy and safety of X + N in a multicenter phase II trial of pts previously treated with anthracycline- and taxane-containing regimens. Methods: Women >18 years of age with pretreated MBC, PS 0–2 and adequate organ function were enrolled to receive a 3-weekly regimen of XN: X 1000mg/m2 twice daily on days 1–14 and N 25mg/m2 on days 1&8, every 3 weeks up to a maximum of 6 cycles, disease progression or unacceptable toxicities. Results: A total of 32 pts were enrolled, median age 58 years (range 41–77), PS 0(74%), 1(19%), postmenopausal (61%). The most frequent sites of metastases were: liver (68%), nodes (36%), lung (36%). 58% of pts had ≥2 metastatic sites. 27 patients (87%) previously failed on anthracycline and taxane chemotherapy regimens. 152 cycles were administered with a median of 3 cycles/pt (range 1–10). Median relative dose intensity was 0.86 (0.51–1.01] for N and 0.85 (0.26–1.03] for X. All pts were evaluable for safety. The most common grade 3/4 clinical adverse events were vomiting (15%), asthenia (9%), and hand-foot syndrome (6%). Grade 3/4 hematological toxicities were: neutropenia (47%), leucopenia (9%), thrombocytopenia (3%). One pt died due to septic shock after the first cycle. 29 pts are evaluable for efficacy: the overall response rate was 52% (4 CR, 11 PR), with stable disease in 8 pts (28%). Median TTP was 7.5 months [95% CI, 5.7–9.8]. Conclusions: Our preliminary data indicate that the combination of X and N has promising clinical activity and good safety in pts with MBC who have failed prior taxane- and anthracycline-containing regimens. No significant financial relationships to disclose.

Mature data on capecitabine (X) + fractionated cisplatin (P) as first-line therapy in patients (pts) with advanced gastric carcinoma (AGC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4075-4075 ◽  
Author(s):  
M. Jin ◽  
L. Shen ◽  
B. Hu ◽  
J. Yu ◽  
Z. Wen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Response Rate ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
First Line ◽  
First Line Therapy ◽  
Highly Active ◽  
Advanced Gastric Carcinoma ◽  
Hand Foot Syndrome ◽  
Grade 3

4075 Background: Gastric cancer is one of the most common malignancies in Asia with an adjusted mortality rate above 20/100,000 population. 5-FU + fractionated P is a standard treatment for AGC in China. In a Korean study by Kim et al., X + P produced a response rate of 55% in pts with previously untreated AGC. Here we present mature efficacy/safety results in Chinese pts with AGC. Methods: 154 pts of a planned population of 120 pts were enrolled between Jun 2002 and Aug 2004. All had measurable AGC (WHO), Karnofsky performance status ≥60, adequate bone marrow, renal and hepatic functions. Prior radiotherapy or adjuvant chemotherapy was permitted. Pts received × 1000 mg/m2 orally bid on days 1–14 + P 20mg/m2/day i.v. on days 1–5, every 3 weeks for 6 cycles. The primary endpoint was time to disease progression (TTP). Results: Baseline characteristics of the 141 evaluable pts (104 men, 37 women) are: median age 54 years (range 23–80), main sites of metastases: lymph nodes 45%, liver 40%, stomach 18%, skin 6%, other 6%, lung 5%, abdomen 4%. The overall response rate was 36%, including 13 complete responses and 38 partial responses. After a median follow-up period of 12 months, the median TTP is 9 months (95% CI, 9–12 months) and the median overall survival is 12 months (95% CI, 12–15 months). Median treatment duration was 6 cycles (range 3–6). The most common treatment-related clinical adverse events (all grades >5%) were: hand-foot syndrome (HFS) 25%, leucopenia 13%, and SGOT abnormality 12%. The most commongrade 3 adverse events were SGPT abnormality 3%, HFS 2%, and anemia 2%. There were no grade 4 adverse events. Most grade 3 adverse events improved or resolved after treatment or interruption except in 1 pt with anemia who withdrew after 2 cycles. Conclusions: X combined with fractionated P is highly active and very well tolerated as first-line treatment for AGC, with comparable results to 5-FU + P. No significant financial relationships to disclose.

Doxorubicin and Paclitaxel Versus Fluorouracil, Doxorubicin, and Cyclophosphamide as First-Line Therapy for Women With Metastatic Breast Cancer: Final Results of a Randomized Phase III Multicenter Trial

2001 ◽  
Vol 19 (6) ◽  
pp. 1707-1715 ◽  
Author(s):  
Jacek Jassem ◽  
Tadeusz Pieńkowski ◽  
Anna Płuzańska ◽  
Svetislav Jelic ◽  
Vera Gorbunova ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Time To Progression ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3

PURPOSE: This phase III trial compared the efficacy and safety of doxorubicin and paclitaxel (AT) to 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) as first-line therapy for women with metastatic breast cancer. PATIENTS AND METHODS: A total of 267 women with metastatic breast cancer were randomized to receive either AT (doxorubicin 50 mg/m2 followed 24 hours later by paclitaxel 220 mg/m2) or FAC (5-fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2), each administered every 3 weeks for up to eight cycles. Patients had to have measurable disease and an Eastern Cooperative Oncology Group performance status of 0 to 2. Only one prior non–anthracycline, nontaxane-containing adjuvant chemotherapy regimen was allowed. RESULTS: Overall response rates for patients randomized to AT and FAC were 68% and 55%, respectively (P = .032). Median time to progression and overall survival were significantly longer for AT compared with FAC (time to progression 8.3 months v 6.2 months [P = .034]; overall survival 23.3 months v 18.3 months [P = .013]). Therapy was generally well-tolerated (median of eight cycles delivered in each arm). Grade 3 or 4 neutropenia was more common with AT than with FAC (89% v 65%; P < .001); however, the incidence of fever and infection was low. Grade 3 or 4 arthralgia and myalgia, peripheral neuropathy, and diarrhea were more common with AT, whereas nausea and vomiting were more common with FAC. The incidence of cardiotoxicity was low in both arms. CONCLUSION: AT conferred a significant advantage in response rate, time to progression, and overall survival compared with FAC. Treatment was well-tolerated with no unexpected toxicities.

Bevacizumab and pegylated liposomal doxorubicin as first-line therapy for locally recurrent or metastatic breast cancer: A multicenter, single-arm phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1030-1030
Author(s):  
C. Rochlitz ◽  
C. Spirig ◽  
T. Ruhstaller ◽  
T. Suter ◽  
M. Bühlmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Liposomal Doxorubicin ◽  
Cardiac Toxicity ◽  
Metastatic Breast ◽  
Pegylated Liposomal Doxorubicin ◽  
Advanced Breast ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3

1030 Background: Bevacizumab in combination with taxanes has become a standard first-line treatment of advanced breast cancer in some countries, but there is no information on its use in combination with pegylated lipsomal doxorubicin in metastatic breast cancer. Therefore, we performed a multicenter, single-arm phase II trial to evaluate the toxicity and efficacy of pegylated liposomal doxorubicin (PLD) and bevacizumab (B) as first-line treatment in advanced breast cancer. Methods: PLD at a dose of 20 mg/m2 and B at 10 mg/kg were infused on days 1 and 15 of each 4-week cycle for a maximum of 6 cycles. Thereafter, B monotherapy was continued at the same dose until progression or toxicity. Primary endpoint was the occurrence of specific toxic events known to strongly interfere with quality of life, i.e., severe cardiac toxicity, any grade 4/5 toxicity, and selected grade 3 nonhematological toxicities (hand-foot-syndrome, cognitive disturbance, CNS hemorrhage, and mucositis/stomatitis). Secondary endpoints included overall response, progression free survival (PFS), time to treatment failure, and duration of response. Eligibility criteria included documentation of metastatic or inoperable breast cancer; measurable disease according to RECIST; erbB2-negativity; LVEF of ≥ 55%; WHO performance status 0 or 1. The study used a Herndon's two-stage design with 14 and 29 patients for stages 1 and 2, respectively. The promising rate of primary toxicity was <15% and the uninteresting rate >33%. The type I error probability was 5% and the power 80%. Results: The trial had to be stopped prematurely because of toxicity after the enrollment of 41 evaluable patients. Among these patients, 16 (39%) had grade 3 hand-foot syndrome, 1 grade 3 mucositis and 1 grade 4 cardiac toxicity. Thus, a total of 18/41 (44%, exact 95% c.i. 28–60%) of all patients had a primary toxicity. Best overall response rate was 23.3% (exact 95% c.i. 12–39%), median PFS was 7.5 months (95% c.i. 4.6–8.1 months). Conclusions: The combination of 2-weekly PLD and B in advanced breast cancer is surprisingly toxic and only modestly active and should not be further investigated. [Table: see text]

Tesetaxel: Activity of an oral taxane as first-line treatment in metastatic breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1016-1016 ◽  
Author(s):  
Andrew David Seidman ◽  
Lee Steven Schwartzberg ◽  
Joyce O'Shaughnessy ◽  
Gabriella D'Andrea ◽  
Peter Rubin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Estrogen Therapy ◽  
Metastatic Breast ◽  
Hypersensitivity Reactions ◽  
Highly Active ◽  
Line Therapy ◽  
Grade 3 ◽  
Metastatic Sites

1016 Background: Tesetaxel, unlike standard taxanes (docetaxel, paclitaxel), is not a substrate for Pgp, a major cause of taxane resistance in tumor models. In a DU4475 breast cancer xenograft that overexpresses Pgp, tesetaxel induced a 94% reduction in tumor size, markedly exceeding the activity of docetaxel (46%) and paclitaxel (26%). Tesetaxel is associated with substantially less neuropathy preclinically than equi-myelotoxic doses of docetaxel. In clinical studies to date, tesetaxel is not associated with hypersensitivity reactions (0% incidence in > 450 patients [pts]), thus eliminating the need for premedication and extended observation. In a prior study, tesetaxel (27-35 mg/m2 Q3 wks) achieved a 38% partial response (PR) rate as 2nd-line therapy in pts with metastatic breast cancer (MBC) who had progressed after multidrug anthracycline-containing regimens. To extend these data, we initiated a phase 2 study of tesetaxel as 1st-line therapy in women with MBC. Methods: Eligibility included MBC; HER2-; ECOG PS 0-1; and adequate organ function. Adjuvant chemotherapy (including taxanes) was allowed. Tesetaxel was administered orally without anti-allergic premedication at a starting dose of 27 mg/m2 once every 3 wks. Overall response rate (ORR; RECIST) was the primary endpoint. Results: All 45 pts have been accrued. Median age is 58 y (range 36-80); median time from diagnosis, 4.0 y (range 0-21); triple negative status, 8 pts at diagnosis, 14 at time of metastasis. Metastatic sites are lung (22 pts), lymph nodes (22), liver (24), and bone (21). Prior treatment includes anti-estrogen therapy (32 pts), adjuvant chemotherapy (31), prior taxane (25), and radiotherapy (28). ORR in 24 pts evaluable for response is 50% (1 CR [4%], 11 PR [46%]); 5 responding pts had prior taxane therapy. Neutropenia is the most common ≥ Grade 3 adverse event with 50% of cases observed after dose escalation to 35 mg/m2; febrile neutropenia and Grade 3 peripheral neuropathy occurred in 2 pts each. There were no hypersensitivity reactions. Conclusions: Tesetaxel is highly active in 1st-line MBC and overcomes multiple limitations of standard taxanes. Updated ORR and PFS for all pts will be presented. Weekly dosing will be evaluated in a new cohort of pts.

Randomized Phase III Study of Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid Plus Oxaliplatin As First-Line Therapy for Metastatic Colorectal Cancer

2008 ◽  
Vol 26 (12) ◽  
pp. 2006-2012 ◽  
Author(s):  
Jim Cassidy ◽  
Stephen Clarke ◽  
Eduardo Díaz-Rubio ◽  
Werner Scheithauer ◽  
Arie Figer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Folinic Acid ◽  
Progression Free Survival ◽  
Phase Iii ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Hand Foot Syndrome ◽  
Grade 3

PurposeTo evaluate whether capecitabine plus oxaliplatin (XELOX) is noninferior to fluorouracil. folinic acid, and oxaliplatin (FOLFOX-4) as first-line therapy in metastatic colorectal cancer (MCRC).Patients and MethodsThe initial design of this trial was a randomized, two-arm, noninferiority, phase III comparison of XELOX versus FOLFOX-4. After patient accrual had begun, the trial design was amended in 2003 after bevacizumab phase III data became available. The resulting 2 × 2 factorial design randomly assigned patients to XELOX versus FOLFOX-4, and then to also receive either bevacizumab or placebo. We report here the results of the analysis of the XELOX versus FOLFOX-4 arms. The analysis of bevacizumab versus placebo with oxaliplatin-based chemotherapy is reported separately. The prespecified primary end point for the noninferiority analysis was progression-free survival.ResultsThe intent-to-treat population comprised 634 patients from the original two-arm portion of the study, plus an additional 1,400 patients after the start of the amended 2 × 2 design, for a total of 2,034 patients. The median PFS was 8.0 months in the pooled XELOX-containing arms versus 8.5 months in the FOLFOX-4–containing arms (hazard ratio [HR], 1.04; 97.5% CI, 0.93 to 1.16). The median overall survival was 19.8 months with XELOX versus 19.6 months with FOLFOX-4 (HR, 0.99; 97.5% CI, 0.88 to 1.12). FOLFOX-4 was associated with more grade 3/4 neutropenia/granulocytopenia and febrile neutropenia than XELOX, and XELOX with more grade 3 diarrhea and grade 3 hand-foot syndrome than FOLFOX-4.ConclusionXELOX is noninferior to FOLFOX-4 as a first-line treatment for MCRC, and may be considered as a routine treatment option for appropriate patients.

Tailored vinorelbine-capecitabine treatment in elderly metastatic breast cancer patients. A SICOG phase II study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10556-10556
Author(s):  
I. Carreca ◽  
G. Iodice ◽  
G. D’Aiuto ◽  
R. Thomas ◽  
R. Costanzo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Severe Toxicity ◽  
Breast Cancer Patients ◽  
Highly Active ◽  
Neutropenic Sepsis ◽  
Hand Foot Syndrome ◽  
Gastrointestinal Side Effects ◽  
Metastatic Sites

10556 Purpose: To determine the antitumor activity of vinorelbine (VNR) and capecitabine (Xeloda) when given together, as first-line treatment, in elderly metastatic breast cancer (MBC) patients. Patients and Methods: MBC patients, aged >65 years, with no prior chemotherapy for metastatic disease, received capecitabine 1,000–1,250 mg/m2 d 1→14 and VNR 20–25 mg/m2 d 1–8, q3wk for a maximum of 6 cycles. Doses of VNR and Xeloda were alternately escalated in each patient (VNR 20→25 on 2nd cycle, Xeloda 1,000→1,250 on 3rd cycle), in absence or relevant hematologic/nonhematologic toxicity. Results: Forty-seven MBC pts., median age 72 (range: 66–82) were enrolled. Metastatic sites: visceral/other = 30/17. Adjuvant chemotherapy: Yes/no = 21/27. The doses were escalated as planned in 24/47 pts. To date, 41/47 pts. are evaluable for response. Three CRs and 25 PRs have been recorded, giving a 68% ORR (Visceral/other = 59%/85%). At a median follow-up of 15.3 months, 19 pts. have progressed, and 18 died, median PFS and OS being 14.1, and 20.3 months, respectively. Toxicity has been in general mild or moderate. Grade 3–4 neutropenia has occurred in 29% of pts., with only 2 episodes of neutropenic sepsis. Severe gastrointestinal side effects have been observed in only 2 pts., while severe mucositis and hand-foot syndrome have never occurred. Conclusions: VNR-Xeloda combination is highly active in elderly MBC patients. The adoption of an intrapatient dose escalation permits to minimize the risk of severe toxicity, without compromising efficacy. The accrual still continues until the planned sample size (60 pts.). No significant financial relationships to disclose.

Long median survival with capecitabine (X) single-agent therapy for patients (pts) with anthracycline- and taxane-pretreated metastatic breast cancer (MBC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10710-10710
Author(s):  
R. Largillier ◽  
P. Fumoleau ◽  
C. Clippe ◽  
V. Dieras ◽  
H. Orfeuvre ◽  
...  
Keyword(s):  
Median Survival ◽  
Single Agent ◽  
Survival Rates ◽  
Metastatic Breast ◽  
Highly Active ◽  
Randomized Phase Ii ◽  
Common Grade ◽  
Duration Of Response ◽  
Grade 3

10710 Background: X (Xeloda) is an oral fluoropyrmidine with consistently high activity in MBC, a good safety profile with little myelosuppression and no alopecia, and the convenience of oral administration. The addition of X to docetaxel in anthracycline-pretreated pts also increases survival. This non-randomized phase II study was conducted to evaluate the efficacy, safety and impact on quality of life (QoL) of X in pts with MBC pretreated with anthracyclines and taxanes. Main findings from this trial have been published previously [Fumoleau et al. Eur J Cancer 2004;40:536–42]. Here we present mature data after a follow-up of 48 months. Methods: Pts with anthracycline- and taxane-pretreated MBC received X 1250 mg/m2 twice daily on days 1–14 every 3 weeks for a median of 6 cycles (range 1–15). Results: Baseline characteristics of the 126 pts enrolled were typical of a pretreated MBC population. X achieved complete/partial response or stable disease in 63% of patients (overall response rate, 28%). Median time to progression was 4.9 months (95% CI: 4.0–6.4).Median duration of response was 5.9 months (95% CI: 4.5–12.7). The only grade 3/4 events occurring in ≥ 10% of patients were diarrhea (10%) and HFS (21%). The most common grade 3/4 laboratory abnormality was granulocytopenia (14%). After a follow-up of 48 months, 8 patients are still alive. Updated median overall survival is 15.9 months (95% CI: 13.5–21.3). 1-, 2- and 3-year survival rates are 63%, 37% and 17%, respectively. QoL assessment showed that X treatment was associated with an increase in mean Global Health Score up to cycle 6, with the increase maintained at subsequent evaluations. Conclusions: X is highly active in patients with anthracycline- and taxane-pretreated MBC, leading to a long median survival of 15.9 months. X is also well tolerated and improves QoL. [Table: see text]

Preliminary results of second-line chemotherapy with vinorelbine and gemcitabine after docetaxel and carboplatin failure in advanced non small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17130-17130
Author(s):  
J. Abou Yared ◽  
G. Chahine ◽  
J. Kattan ◽  
F. Farhat ◽  
W. Moukadem ◽  
...  
Keyword(s):  
Objective Response ◽  
Response Duration ◽  
Response To Therapy ◽  
First Line ◽  
Preliminary Results ◽  
First Line Therapy ◽  
Line Therapy ◽  
Grade 3 ◽  
Metastatic Sites ◽  
Line Chemotherapy

17130 Background: To evaluate the efficacy and safety of a doublet platinum-free therapy based on Vinorelbine and Gemcitabine in the salvage treatment of patients with advanced NSCLC, previously treated with Carboplatin and Docetaxel. Methods: We conducted a phase II study with the combination of vinorelbine 30 mg/m2 and gemcitabine 1000 mg/m2 d1 d8 / 3w. Eligible were patients with histologically proven advanced or metastatic NSCLC who were refractory or progressed after first-line chemotherapy combining Docetaxel and Carboplatin. Results of this first-line therapy were already reported (Proc. Am. Soc. Clin. Oncol. 2005, abstr 7330). Patients must have measurable disease, PS ≤ 2, life-expectancy ≥ 3 months, adequate hematologic, liver and renal functions. Response to therapy was evaluated according to RECIST guidelines. Toxicities were assessed according to the national cancer institute (NCI) common toxicity criteria 3.0. Results: From August 2004 to September 2005, 28 patients were enrolled. Median age was 63 years (range, 44 to 77) with 18 males and 10 females. A total of 109 cycles were delivered with a median of 4 cycles per patient (range, 1 to 9). Mean metastatic sites were lymph nodes in 9 pts, liver in 6 pts and pleura in 5 pts. 26 patients were evaluable for response (1 patient too early and 1 pt lost of follow-up). 6 patients responded partially (23%), one of them was initially resistant to the first-line therapy. 11 patients had stable disease (42%). Mean objective response duration was 7 months (range, 5 to 10+). Main toxicities (grade 3/4) were: anemia in 4 patients, neutropenia in 7 patients, leucopenia in 8 patients and lymphopenia in 4 patients. Neutropenic fever was encountered in only one patient. Non-hematological toxicities grade 3/4 were universally absent. No dose reduction or treatment delay related to toxicity was necessary. Conclusion: The study is still ongoing and more patients are expected to define time to progression and survival. However, these preliminary results were encouraging with low toxicity profile. No significant financial relationships to disclose.

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