Randomized open label phase II study of pegilated liposomal doxorubicine (PLD) four or six-week scheduled in metastatic breast cancer (MBC) patients (p)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10751-10751 ◽  
Author(s):  
M. Ruiz ◽  
J. L. Bayo ◽  
J. A. Moreno Nogueira ◽  
J. Dorta ◽  
A. M. Casas ◽  
...  
Keyword(s):  
Median Time ◽  
Ductal Carcinoma ◽  
Metastatic Breast ◽  
Stage Iv ◽  
Dose Intensity ◽  
Primary Objective ◽  
Comparable Efficacy ◽  
Toxicity Profile ◽  
Open Label ◽  
Ecog Ps

10751 Background: PLD has the advantage of delivering the active anthracycline directly to the tumour site, provide comparable efficacy to conventional doxorubicin with a more favourable toxicity profile and significantly less cardiotoxicity. The most frequent dosing schedule is 50 mg/m2 every 4 weeks. Recent studies have shown that PLD 60 mg/m2 every 6 weeks is an active and well tolerated treatment, and could be more convenient for the p. The primary objective was to evaluate response rate in six- and four-week schedule (arms A and B). Secondary objective was toxicity profile. Methods: P histologically confirmed of MBC, age 18–75 years old, ECOG PS ≤ 2, at least one measurable lesion and adequate bone marrow, renal, hepatic and cardiac function, were eligible. Prior chemotherapy with anthracyclines for MBC or adjuvant anthracycline-based regimen in the previous 12 months was not allowed. P were randomly assigned to receive PLD 60 mg/m2 i.v. in 1 hour every 6 weeks (arm A) or PLD 50 mg/m2 i.v. in 1 hour every 4 weeks (arm B). Results: Ten p have been included in the interim analysis over 11 enrolled, with median age of 50 years, ECOG PS 0–1 70% and stage IV 50%. Median time from diagnosis of metastatic disease was 9.2 months. Histology: 80% of p had ductal carcinoma, 10% lobular and 10% undifferentiated. Main tumour locations were lung (60%), liver (60%) and bone (40%). Two p had positive hormonal receptor status in arm A and 4 in arm B. Previous treatment included chemotherapy (80%), hormonotherapy (80%) and radiotherapy (40%). Up to date, a total of 15/17 cycles (median 3/3, range 1–6/1–5) were administered. Absolute dose intensity was 2.2 mg/day in arm A and 3.0 mg/day in arm B. Two p were not evaluated and over 8 evaluable p for efficacy (4 A and 4 B), 2 achieved partial response in arm A and 1 in arm B. Median time to progression was 168 days in arm A and 104 in arm B. The only grade III/IV toxicity was mucositis and stomatitis in 4 p. The most common grade I/II toxicities were palmar-plantar erythrodysesthesia (5p), anorexia (4p) and alopecia (4p). Conclusions: PLD at 50 mg/m2 every 4 weeks and 60 mg/m2 every 6 weeks are effective and well tolerated regimens in MBC p. The most relevant adverse events were mucositis and palmar-plantar erythrodysesthesia. No significant financial relationships to disclose.

Phase I study of intravenous (IV) milataxel in adult patients with advanced malignant tumors

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 2037-2037 ◽  
Author(s):  
E. Bourbouloux ◽  
M. Campone ◽  
J. B. Vermorken ◽  
M. Martin ◽  
C. Sessa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Dose Escalation ◽  
Malignant Tumors ◽  
Metastatic Breast ◽  
Dose Intensity ◽  
Median Number ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Eligibility Criteria ◽  
Ecog Ps

2037 Background: M (TL139, MAC-321) is a novel taxane with activity in human xenograft models against tumors resistant to paclitaxel. The maximum tolerated dose (MTD) when given IV every 3 weeks was 35 mg/m2. The current study was designed to determine if the dose intensity of M could be increased by a weekly IV schedule. Methods: The primary objective of the study was to determine the maximum tolerated dose (MTD), the dose limiting toxicity (DLT) and the recommended dose (RD) for phase II. Secondary objectives were pharmacokinetic (PK)/pharmacodynamic (PD) parameters of M given IV weekly and a preliminary estimate of efficacy in an expanded cohort at the RD. Key pt eligibility criteria included in adult pts with refractory malignant tumors, ECOG PS <3 and adequate hematologic, hepatic and renal function. Patients were not allowed concurrent strong inhibitors of cytochrome p450 3A4. Dose escalation was based on Fibonacci method. At the RD, additional pts with tumors that typically respond to taxane treatment were added. PK data were obtained on day 1 and 15. Results: A total of 32 pts were treated, 15 (6 females, 9 males) in the dose escalation part and 17 (15 females, 2 males) in the MTD confirmation part. The median number of doses was 11 (range 1–18). In the dose escalation phase, 3, 4, and 3 pts were treated at 8, 12, and 16 mg/m2 IV weekly without DLT. At 20 mg/m2, 2 of 5 pts developed DLT (1 pt - myalgia and neuropathy, 1 pt grade 4 neutropenia > 5 days in duration). The RD was 16 mg/m2 weekly. 17 more pts were treated at the RD. The most frequent grade 3 or 4 adverse events were asthenia (19%), nausea (9%), parethesia (9%) and neuropathy (9%). Of the 10 pts with breast cancer who were evaluable for response, one had a PR. Another breast cancer pt with a PR was a protocol violation and was not evaluable. In 20 pts at the MTD, the Tmax was 4 hr, the Cmax was 51.97 ng/mL, AUC 2711 ng*hr/mL, and the Vss was 1496 L/m2. Conclusions: Milataxel had an RD of 16 mg/m2 IV per week. Objective responses were observed in pts with metastatic breast cancer. No significant financial relationships to disclose.

Phase II study of neoadjuvant docetaxel (T), doxorubicin (A) and capecitabine (X) in locally advanced or inflammatory breast cancer (LABC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11092-11092 ◽  
Author(s):  
G. Perez-Manga ◽  
M. Mendez ◽  
M. I. Palomero ◽  
R. Quiben ◽  
J. Belon
Keyword(s):  
Breast Cancer ◽  
Locally Advanced ◽  
Bilateral Breast Cancer ◽  
Dose Intensity ◽  
Hepatic Function ◽  
Primary Objective ◽  
Additional Patient ◽  
High Survival ◽  
Toxicity Profile ◽  
Ecog Ps

11092 Background: Studies suggest that chemotherapy + surgery + radiotherapy gives a high survival rate in patients with LABC. Primary objective was to evaluate response rate. Secondary endpoints were time to progression and toxicity profile of neoadjuvant T, A and X in LABC. Methods: Eligibility: histologically confirmed LABC, ECOG PS =2, age =75 years, LVEF >50%, and adequate bone marrow, renal and hepatic function. Prior systemic therapy, surgery or radiotherapy for breast cancer was not allowed. Patients with invasive bilateral breast cancer were not included. Treatment: T (30 mg/m2) iv day 1, 8 and 15, A (50 mg/m2) iv day 1 and X (1500 mg/m2 o.d.) days 1–14, in a 4-week course repeated for up to 4 cycles followed by surgery. According to investigator criteria patients received a maximum of 6 cycles. Radiotherapy and hormone therapy were allowed after surgery. Expression of markers was determined by immunohistochemistry before chemotherapy. Results: 43 patients were included in this analysis, median age 48 years (25–73). ECOG PS was 0 in 37% of patients and 1 in 63%. Hormonal receptor status was ER+ 44%, PR+ 34% and C-erb2+ 59%. In total, 157 cycles (median 4, range 2–4) were given. Median relative dose intensity was 86% for T, 92% for A and 88% for X. Of 43 patients evaluable for efficacy, 13 achieved CR, 24 PR and 1 PD resulting in an ORR of 97% (CI 95%: 92–100). Surgery was performed in 40 patients: 4 (10%) achieved pathologic CR and one additional patient had non-invasive carcinoma. Grade III/IV toxicity per patient was neutropenia (74%), leukopenia (56%), febrile neutropenia (9%), mucositis (12%), diarrhea (12%), nausea/vomiting (5%), dysgeusia (2%) and asthenia (2%). Median follow-up time was 19.5 months. Conclusions: Neoadjuvant T, A and X every 28 days for 4 cycles is an active regimen in LABC with a manageable toxicity profile before surgery. No significant financial relationships to disclose.

scholarly journals Oral vinorelbine and cisplatin as first-line therapy for advanced squamous NSCLC patients: a prospective randomized international phase II study (NAVoTrial 03)

2021 ◽  
Vol 13 ◽  
pp. 175883592110229
Author(s):  
Francesco Grossi ◽  
Piotr Jaśkiewicz ◽  
Marion Ferreira ◽  
Grzegorz Czyżewicz ◽  
Dariusz Kowalski ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Current Knowledge ◽  
Progression Free Survival ◽  
Primary Objective ◽  
Comparable Efficacy ◽  
Open Label ◽  
Oral Vinorelbine ◽  
First Line Therapy ◽  
Nsclc Patients

Objective: The study investigated the efficacy and safety of oral vinorelbine-cisplatin (OV-CDDP) and gemcitabine-cisplatin (GEM-CDDP) in patients with squamous non-small cell lung cancer (sq-NSCLC). Patients and methods: This was an open-label, prospective, multicenter, international phase II study that enrolled untreated patients with advanced sq-NSCLC. Patients were randomized to receive 3-week cycles of either 60–80 mg/m2 OV days 1 and 8 in combination with 80 mg/m2 CDDP day 1 (arm A) or 1250 mg/m2 GEM days 1 and 8 in combination with 75 mg/m2 CDDP day 1 (arm B). After four cycles, patients without disease progression continued maintenance dose of OV or GEM until progression or unacceptable toxicity. The primary objective was disease control rate (DCR). Secondary objectives included progression-free survival (PFS), time to treatment failure (TTF), overall survival (OS), safety, and quality of life (QoL). Results: A total of 114 patients with sq-NSCLC were randomized, and 113 were treated (57 in arm A and 56 in arm B). DCR was high in both arms: 73.7% (95%CI: 62.4–100.0) in arm A and 75.0% (95%CI: 63.7–100.0) in arm B. Median PFS and TTF were similar in arm A and B 4.2 and 2.8 months, and 4.3 and 3.1 months, respectively. Even though the difference was not significant, the OS was 10.2 for arm A and 8.4 months for arm B. The safety profiles were consistent with the current knowledge of adverse events. QoL results revealed an improvement in patients under OV treatment. Conclusion: The OV-CDDP combination showed comparable efficacy to GEM-CDDP with acceptable safety profile and enhanced patients’ QoL. Trial registration: The study was registered under EudraCT number 2012-003531-40.

First-MIND: A phase Ib, open-label, randomized study to assess safety of tafasitamab (tafa) or tafa + lenalidomide (LEN) in addition to R-CHOP in patients with newly diagnosed DLBCL.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7540-7540
Author(s):  
David Belada ◽  
Katerina Kopeckova ◽  
Juan Miguel Bergua ◽  
Marc André ◽  
Ernesto Perez Persona ◽  
...  
Keyword(s):  
Performance Status ◽  
Randomized Study ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Dose Intensity ◽  
Newly Diagnosed ◽  
Open Label ◽  
Bulky Disease ◽  
Phase Ib ◽  
Ecog Ps

7540 Background: Tafasitamab is a humanized, Fc-modified anti-CD19 monoclonal antibody that enhances antibody-dependent cellular cytotoxicity and phagocytosis. It is FDA-approved with LEN for adult patients (pts) with relapsed/refractory (R/R) DLBCL ineligible for autologous stem cell transplantation. First-MIND (NCT04134936) is a Phase Ib, open-label, randomized study of tafa + R-CHOP or tafa + LEN + R-CHOP in newly diagnosed DLBCL. Methods: Eligible pts were ≥18 years, treatment-naïve, with histologically confirmed DLBCL not otherwise specified, international prognostic index (IPI) 2–5 and ECOG performance status (PS) 0–2. Pts with known double- or triple-hit and transformed lymphoma were excluded. Treatment (Tx) comprised six 21-day cycles of tafa (12 mg/kg IV, Day [D] 1, 8, 15) + R-CHOP (arm A) or tafa (12 mg/kg IV, D1, 8, 15) + LEN (25 mg orally, D1–10) + R-CHOP (arm B). G-CSF and VTE prophylaxis was mandatory. Primary objective is safety; secondary objectives are ORR, PET-CR rate at end of Tx, PFS, long-term safety, pharmacokinetics, immunogenicity. Results: From Dec 2019 to Aug 2020, 83 pts were screened in Europe and the US; 66 were randomized (33 per arm). Data cut-off for this analysis: 9 Dec 2020; study is ongoing. Median age was 64.5 years (range 20–86). Overall, 30% (20/66) of pts were ≥70 years and many had high-risk disease: IPI 2 29%, IPI 3 46%, IPI 4 26%. ECOG PS: 47% of pts were ECOG PS 0, 44% PS 1, 9% PS 2. Most pts had stage III/IV disease (92%); 46% had bulky disease. All pts experienced a treatment-emergent adverse event (TEAE). Grade ≥3 neutropenia and thrombocytopenia occurred in 54.5% and 12.1% (arm A) and 66.7% and 30.3% (arm B) of pts, respectively (Table). Serious TEAEs occurred in 42.4% (arm A) and 51.5% (arm B) of pts. There were three deaths, unrelated to tafa and/or LEN (sepsis, urosepsis, and COVID-19 pneumonia). R-CHOP dose intensity was maintained in both arms. Among 60 pts who completed tumor assessments after cycle 3, ORR was 89.7% (arm A) and 93.5% (arm B). Conclusions: These data suggest R-CHOP + tafa or tafa + LEN is tolerable in pts with Tx-naïve DLBCL and that R-CHOP dosing is not affected. Toxicities are similar to those expected with R-CHOP or R-CHOP + LEN. Updated safety and early efficacy data will be presented at the conference. Clinical trial information: NCT04134936. [Table: see text]

scholarly journals 413 Toripalimab in combination with concurrent chemoradiation in patients with advanced/metastatic esophageal carcinoma: protocol for a single-arm, prospective, open-label, phase II clinical trial

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A444-A444
Author(s):  
Lei Wu ◽  
Yi Wang ◽  
Gang Wan ◽  
Jiahua Lv ◽  
Qifeng Wang ◽  
...  
Keyword(s):  
Esophageal Carcinoma ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Stage Iv ◽  
Predictive Biomarkers ◽  
Primary Objective ◽  
High Morbidity ◽  
Efficacy And Safety ◽  
Open Label ◽  
Carboplatin Auc

BackgroundEsophageal carcinoma is a disease with high morbidity and mortality in China and, recently, Immune checkpoint inhibitors(ICIs) combined with chemotherapy have shown good efficacy and safety for treatment; however, some patients still suffer from tumor progression or metastasis after treatment. Clinical studies have confirmed that immunotherapy combined with chemoradiotherapy can significantly improve the prognosis of patients with advanced esophageal cancer, but the efficacy and safety of adding radiotherapy to immunotherapy and chemotherapy have been less reported.MethodsThis is an open-label, single-arm, and single-center phase ll trial.Patients with unresectable stage IV esophageal squamous cell carcinoma(ESCC) who had not received prior systemic therapy were enrolled. The patients were treated with two cycles of toripalimab (240 mg d1, Q3W) combined with induction chemotherapy (paclitaxel 135–175 mg/m2, d1+carboplatin AUC=4–6, d1, Q3W), sequentially combined with concurrent chemoradiotherapy (30–50 Gy in 15–25 fractions, paclitaxel 135–175 mg/m2, d1+carboplatin AUC=4–6 d1, Q3W), followed by maintenance treatment with toripalimab (240 mg d1, Q3W) for 1 year. The primary objective of this trial is to evaluate the progression-free survival (PFS) of this combination therapy;and the secondary objective is related to the assessment of objective response rate (ORR), the disease control rate (DCR), the duration of remission (DOR), the 1- and 2-year overall survival(OS) rates, the safety and tolerability of patients to treatment, and the identification of the changes in the health-related quality of life (HRQoL) of patients. Furthermore, we aimed to identify predictive biomarkers (such as the expression of PD-L1 ctDNA and cytokines) and to explore the relationship between these biomarkers and tumor response to the study treatment.AcknowledgementsWe thank all the participants and their advisors involving in this study. We owe thanks to the patients in our study and their family members.Trial RegistrationChiCTR(ChiCTR2100046715). Registered on the 27th of May 2021.Ethics ApprovalThe study protocol is approved by Ethics Committee of Sichuan Cancer Hospital (SCCHEC-02-2021-021).Changes to the protocol will be communicated via protocol amendment by the study principal investigators. Written informed consent will be obtained from all participants.

scholarly journals Difficulty Diagnosing a Brain Tumor during Clinical Maintenance of a Complete Response to anti-HER2 Treatments for Metastatic Breast Cancer: A Case Report

2020 ◽  
Vol 13 (3) ◽  
pp. 1311-1316
Author(s):  
Ryoko Semba ◽  
Yoshiya Horimoto ◽  
Atsushi Arakawa ◽  
Yoko Edahiro ◽  
Tomoiku Takaku ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Brain Tumor ◽  
Ductal Carcinoma ◽  
Metastatic Breast ◽  
Stage Iv ◽  
B Cell Lymphoma ◽  
High Dose ◽  
Her2 Positive ◽  
Stage Iv Breast Cancer ◽  
The Right

A 46-year-old woman with erythema of the right breast presented to our hospital and was diagnosed with stage IV breast cancer (HER2-positive invasive ductal carcinoma). She received 4 courses of anthracycline-based regimens and 4 courses of trastuzumab + pertuzumab + docetaxel (Tmab + Pmab + DTX). Since she responded well to these therapies, only Tmab + Pmab was continued thereafter. Twenty-three months after starting treatment, she developed a headache. A tumor was identified in the right temporal lobe. Craniotomy was performed for definitive diagnosis. Intraoperative pathological assessment suggested the tumor to be brain metastasis of breast cancer. However, the final pathological diagnosis was diffuse large B-cell lymphoma of central nervous system (DLBCL-CNS) based on re-assessment with immunohistochemical examinations. Therefore, the Tmab + Pmab was discontinued, and 6 courses of high-dose methotrexate therapy were administered. This case highlights the importance of considering rare entities, such as DLBCL, when diagnosing a solitary brain tumor in a patient with a primary cancer, based on imaging and pathological findings.

Abbreviated Treatment with Short-Course Dose-Adjusted EPOCH and Rituximab (DA-EPOCH-R) Is Highly Effective in AIDS-Related Lymphoma (ARL).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3111-3111 ◽  
Author(s):  
Kieron Dunleavy ◽  
Richard Little ◽  
Juan Gea-Banacloche ◽  
Nicole Grant ◽  
Seth Steinberg ◽  
...  
Keyword(s):  
Stage Iv ◽  
Dose Intensity ◽  
Cell Loss ◽  
Hematological Toxicity ◽  
Hiv Viral Load ◽  
Cd4 Cell Count ◽  
Short Course ◽  
Ecog Ps ◽  
Cd4 Cell

Abstract In ARL, rituximab may slightly improve CHOP response but is associated with greater toxicity (Proc Am Soc Hem102:1488, 2003). We hypothesized that the addition of rituximab to DA-EPOCH may increase fractional tumor cell kill and allow fewer treatment cycles and lower immune suppression. Patients received DA-EPOCH-R (E=etoposide 50 mg/m2/d, O=vincristine 0.4 mg/m2/d and H=doxorubicin 10 mg/m2/d all CIV d 1–4 (96 hours); C=cyclophosphamide 750 mg/m2 IV d5; P=prednisone 60 mg/m2 PO qd d1–5 and R=rituximab 375 mg/m2 IV d1 and 5) with G-CSF. Prophylactic IT MTX x 6 was administered. HAART was discontinued before and recommenced after DA-EPOCH-R. Unlike our previous study of DA-EPOCH in ARL (BLOOD101:4653, 2003) where the dose of C was lower and based on CD4 cell count, all patients on this study received full dose C on cycle 1 with subsequent reduction if the ANC nadir was < 500/mm3 for ≥ 2 days. Patients received 1 cycle beyond CR, based on CT and PET, for a minimum of 3 cycles. Characteristics of 21 patients include median (range) age 39 (9–61) years; IPI 3 (0–4); ECOG PS 2 (1–4); CD4 212 (0–674) cells/mm3 and HIV viral load 53100 (0– 286472) RNA copies/mL. Additionally, male sex 17 (81%); LDH> nl 15 (71); stage IV 15 (71%) and histology with diffuse large B-cell 9 (90%) and Burkitt’s lymphoma 2 (10%). The 18 patients who completed treatment (2 TE; 1 NE) received a median (range) of 3 (3–5) cycles. Responses are CR/CRu 15 (83%); PR 1 (6%) and NR 2 (11%). At 19 mos median follow-up, overall PFS and OS are both 77%, and both 90% in patients with CD4 > 100 cells/mm3. Treatment outcome of DA-EPOCH-R is similar to DA-EPOCH (CR 74% and PFS 73% at 53 months) but with significantly shorter treatment (median cycles 3 vs. 6). Toxicity on 57 cycles include ANC < 500/mm3 on 27 (47%); platelets < 50,000/mm3 on 15 (26%) and; fever/neutropenia on 20 (35%) cycles. DA-EPOCH-R produced a median (range) CD4 cell decrement of 64 (−541 to + 239) cells/mm3 compared to 189 (−973 to +19) with DA-EPOCH. Hematological toxicity is higher with DA-EPOCH-R compared to DA-EPOCH with ANC < 500/mm3 47% vs 30% and fever/neutropenia 35% vs. 13%, respectively, likely due to higher C dose intensity and/or rituximab. Other toxicities are similar. Abbreviated DA-EPOCH-R is equivalent to DA-EPOCH x 6 and appears to produce less CD4 cell loss. Accrual continues. Figure Figure

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.

Randomized phase II study of biweekly gemcitabine (gem)-paclitaxel (pac), gem-carboplatin (carb) and gem-cisplatin (cis) as first-line treatments in metastatic breast cancer (MBC) after anthracycline failure

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1099-1099 ◽  
Author(s):  
B. Xu ◽  
Z. Jiang ◽  
S. Kim ◽  
S. Yu ◽  
J. Feng ◽  
...  
Keyword(s):  
Performance Status ◽  
Metastatic Breast ◽  
Stage Iv ◽  
Ecog Performance Status ◽  
Eligibility Criteria ◽  
Dominant Type ◽  
Tumor Involvement ◽  
Number Of Cycles ◽  
Ecog Ps ◽  
Tumor Types

1099 Background: Biweekly gem-pac and gem-cis regimens have shown promising activity and safety in different tumor types. In MBC biweekly gem-pac is active and well tolerated. The aim of this multi-country study is to evaluate the efficacy and safety of gem in combination with pac, carb or cis on a biweekly schedule in patients (pts) with MBC. Methods: Major eligibility criteria included: tissue diagnosis of stage IV breast carcinoma; prior anthracycline therapy; ECOG performance status (PS) of 0 or 1; and written informed consent. Pts were randomized to receive gem 2500 mg/m2 in combination with pac 150 mg/m2 (Arm A), carb AUC 2.5 (Arm B) or cis 50 mg/m2 (Arm C) on day 1 of 2-week cycles. The primary endpoint was response rate, with safety a secondary endpoint. Results: This interim analysis was planned to occur when patient enrollment had reached 50% (75/150 pts), at which point there were 26 pts in Arm A, 25 in Arm B and 24 in Arm C, with 12 pts still on treatment. The baseline characteristics were similar in the three arms, including mean age (Arm A 50.2 yr, Arm B 46.1, Arm C 47.3); ECOG PS (PS 0: 50.0%, 64.0%, 54.2%); mean number of sites of tumor involvement (2.9, 2.6, 2.7); dominant type of metastasis (visceral: 73.1%, 80.0%, 79.2%); and disease-free interval (<24 mo: 53.8%, 60.0%, 41.7%). The mean number of cycles was 6.4, 6.0 and 5.8. There was a partial response in 5/26 efficacy qualified pts (19.2%), 5/25 pts (20.0%) and 2/23 pts (8.7%) in Arms A, B and C, respectively, stable disease in 10 pts (38.5%), 9 pts (36.0%) and 9 pts (39.1%), and progressive disease in 5 pts (19.2%), 6 pts (24.0%) and 6 pts (26.1%). There were no treatment-related deaths. Conclusions: The three regimens appear to show activity and have manageable toxicity when given on a biweekly schedule. [Table: see text] No significant financial relationships to disclose.

An attempt to correlate “comprehensive geriatric assessment” (CGA), treatment assignment and clinical outcome in elderly cancer patients: Results of a phase II open study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19592-19592
Author(s):  
G. Mantovani ◽  
E. Massa ◽  
G. Astara ◽  
C. Madeddu ◽  
F. M. Tanca ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Clinical Response ◽  
Cancer Patients ◽  
Phase Ii ◽  
Open Study ◽  
Stage Iv ◽  
Dose Intensity ◽  
Elderly Age ◽  
Objective Clinical Response ◽  
Ecog Ps

19592 Background and Methods: The design was a prospective Phase II open study. Elderly (age =65 years) cancer patients (pts) of different sites were assigned to 3 different CGA categories: “fit”, “intermediate” and “frail”. Therefore, an appropriate treatment was administered and the clinical outcome was assessed. “Fit” pts were assigned standard chemotherapy, “intermediate” pts tailored (chemo-) therapy, “frail” pts monochemotherapy (as “supportive” therapy) or only “supportive care”. The primary endpoint of the study was to correlate CGA with treatment and clinical outcome which was based on: objective clinical response (RECIST), ECOG PS, toxicity (NCI CTC v.3), survival. Patients who completed at least 3 months of treatment were evaluable. At December 2006, 136 pts were enrolled; 114 (mean age 73.6 years) 104 of whom stage IV were evaluable: 36 “fit”, 36 “intermediate” and 42 “frail”. At baseline no difference was found between the CGA categories as for clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). Results: At 3 months the objective clinical response to the assigned treatment was: 9 CR, 9 PR, 13 SD and 5 PD for “fit” pts; 9 PR, 14 SD and 13 PD for “intermediate” pts; 6 PR, 11 SD and 25 PD for “frail” pts. As for the correlation of CGA categories with treatment and clinical outcome: a significantly higher OR, particularly CR, in favor of fit pts was observed, ECOG PS was maintained significantly higher in frail pts, toxicity was the highest in intermediate pts, the dose intensity was highest in fit pts. At the multivariate regression analisys the independent predictive factors for the clinical response were initial CGA and dose intensity. Conclusions: The study confirms: 1) Fit pts should be treated with the most active regimens not differently from adult pts; 2) the “intermediate” group should be probably better assessed as for inclusion criteria; 3) frail pts need a more exhaustive assessment of the quality of life currently not included in the CGA. In conclusion, the CGA assessment is strongly recommended as an essential tool for the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited. No significant financial relationships to disclose.

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