Feasibility of an adapted schedule of carboplatin plus paclitaxel in elderly women with advanced ovarian cancer: A retrospective cohort.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5546-5546
Author(s):  
Benjamin Nicaise ◽  
Soraya Mebarki ◽  
Mathilde Gisselbrecht ◽  
Elisabeth Ashton ◽  
Henri Azais ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Progressive Disease ◽  
Elderly Women ◽  
Advanced Ovarian Cancer ◽  
Early Discontinuation ◽  
Grade 3 ◽  
Vulnerable Elderly ◽  
Dose Delay ◽  
Dose Reductions ◽  
Unacceptable Toxicity

5546 Background: The EWOC-1 trial compared Carboplatin monotherapy (C mono) to two different Carboplatin + Paclitaxel (CP) regimens (weekly or 3-weekly) in vulnerable elderly patients treated for advanced ovarian cancers (OC). This study was closed prematurely because of a worse outcome in the C mono group. Both CP regimens were equivalent in terms of feasibility and efficacy with different toxicity profiles. Optimal CP regimen in elderly patient is still unknown. Here we propose a study of another adapted regimen of CP (aCP) performed in elderly patients in our institution. Methods: We retrospectively analyzed OC patients ≥ 70 years who received a Carboplatin AUC 4-5 d1q3week + Paclitaxel 80 mg/m² d1-d8 q3week regimen between 2015 and 2019. Primary endpoint was treatment feasibility according to the EWOC-1 standard: completion of 6 courses of chemotherapy without early stopping for disease progression, death or unacceptable toxicity (adverse event (AE) related to chemotherapy or treatment procedure leading either to early treatment stopping, to an unplanned hospital admission or to death or to a dose delay lasting more than 14 days or more than 2 dose reductions). Results: We identified 36 pts with a median age of 79 years (table). All patient but one had an ONCODAGE-G8 score ≤ 14, 30.6% of patients had a comorbidity Charlson’s index > 4 and 52.5% had an albumin rate < 35 g/L. The feasibility endpoint was met in 58.3% of patients (IC95% = [25.6; 57.8]). Main causes of treatment failure (TF) were early discontinuation because of toxicity in 6 patients (16.7%) and progressive disease in 3 patients (8.33%). Median PFS was 35.3 months (IC95% = [22.7; NR]) and median OS was 62.1 months (IC95% = [31.4.0; NR]). The most frequent AE were asthenia (all grades = 94.4%, grade 3-4 = 13.9%), anemia (all grades = 94.4%, grade 3-4 = 27.8%), neutropenia (all grades = 66.7%, grade 3-4 = 38.9%) and neuropathy sensory (all grades = 61.1%, no grade 3-4). Non high-grade-serous histological type and a poor Charlson’s score were associated with a higher rate of TF (100% and 63.6%, respectively). Conclusions: These results are consistent with the findings of the EWOC-1 trial in both CP regimens and suggest that aCP could be non-inferior with an acceptable toxicity profile. Further prospective and comparative studies are mandatory to confirm this trend and to better identify predictive factors of TF in OC elderly patients.[Table: see text]

Updated results from a randomized phase II dose-ranging study of the JAK2-selective inhibitor SAR302503 in patients with myelofibrosis (MF).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7109-7109 ◽  
Author(s):  
Animesh Dev Pardanani ◽  
Catriona H. M. Jamieson ◽  
Nashat Y. Gabrail ◽  
Claudia Lebedinsky ◽  
Guozhi Gao ◽  
...  
Keyword(s):  
High Risk ◽  
Phase Ii ◽  
Median Number ◽  
Randomized Phase Ii ◽  
Night Sweats ◽  
Dose Ranging ◽  
Grade 3 ◽  
Number Of Cycles ◽  
Dose Reductions ◽  
Unacceptable Toxicity

7109 Background: We previously reported results of treating MF patients with 3 cycles of 300, 400, or 500 mg of SAR302503 (NCT01420770; Blood 2012;120:21 Abs 2837). This is a report of efficacy and safety after 6 cycles. Methods: Patients ≥18 years of age with intermediate-2 or high-risk MF and splenomegaly were eligible. SAR302503 is administered orally, once a day in consecutive 4-week cycles until disease progression or unacceptable toxicity. Spleen response (≥35% reduction in spleen volume vs baseline) was assessed by MRI/CT (blinded independent central review). Results: 31 patients were enrolled (n=10 in the 300 and 400 mg groups; n=11 to 500 mg). Risk status was balanced in all but the 300 mg group (70% high-risk). Most patients were JAK2V617F positive (90%) and blood transfusion independent (81%). Spleen response rates at the end of cycle (EOC) 6 (secondary end point) were 30% (3/10) in the 300 mg group, 60% (6/10) with 400 mg, and 55% (6/11) with 500 mg compared with EOC 3 rates of 30%, 50%, and 64%, respectively. One patient on 500 mg who had a spleen response at EOC 3 (39% reduction), but not at EOC 6 (25% reduction) had dose reductions to 200 mg due to anemia. Median number of cycles was 13 (range, 2–17) and 24 patients have been on treatment >12 months. SAR302503 reduced baseline constitutional symptoms at the EOC 3, with the greatest responses for night sweats in 14/15 patients (93%), itching 10/14 (71%), early satiety and abdominal pain, each in 10/18 (56%). Most common adverse events were anemia and diarrhea, with grade 3–4 rates of 58% and 13%, respectively. The rate of grade 3–4 thrombocytopenia was 16%. There was no grade 3–4 neutropenia. The diarrhea rate tended to decrease after the first 2 treatment cycles. There have been no reports of withdrawal syndrome after stopping SAR302503. Median JAK2V617F allele burden was 93% at baseline, 87% at the EOC 3, and 78% at EOC 6 in 19/26 patients who had available samples. The expression of 22 of 97 cytokines was significantly regulated (≥1.5 fold difference; p<0.05) after cycle 1. Conclusions: In this Phase II trial, continued treatment with SAR302503 was associated with clinically meaningful reductions in splenomegaly. Symptom data will be updated. Clinical trial information: NCT01420770.

Phase II study of antidisialoganglioside antibody, dinutuximab, in combination with GM-CSF in patients with recurrent osteosarcoma (AOST1421): A report from the Children’s Oncology Group.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10508-10508
Author(s):  
Pooja Hingorani ◽  
Mark D. Krailo ◽  
Allen Buxton ◽  
Paul R. Hutson ◽  
Justin Davis ◽  
...  
Keyword(s):  
Progressive Disease ◽  
Adolescent And Young Adult ◽  
Sufficient Evidence ◽  
Gm Csf ◽  
Phase 2 Study ◽  
Accrual Rate ◽  
Resected Tumor ◽  
Grade 3 ◽  
Unacceptable Toxicity ◽  
Clinical Trial Information

10508 Background: Treatment of patients with recurrent osteosarcoma (OS) is challenging and novel effective therapies are urgently needed. This study evaluated disease control rate (DCR) in patients with recurrent pulmonary OS, when treated with dinutuximab plus cytokine therapy as compared to a historical benchmark. The rationale for dinutuximab was the ubiquitous ( > 95%) GD2 positivity in OS tumors and cell lines. Methods: AOST1421 was a single-arm phase 2 study. Patients with recurrent pulmonary OS in complete surgical remission were eligible. Patients received five cycles of dinutuximab 70mg/m2/cycle with GM-CSF. Two different dinutuximab infusion schedules were used - 35mg/m2/day over 20 hours (2-day) and 17.5mg/m2/day over 10 hours (4-day) schedule. Primary end point was DCR, defined as proportion of patients event-free at 12 months from enrollment. Events were progressive disease or death within 12 months attributed to treatment or progression. The historical benchmark was AOST0221 with a 12-month DCR of 20% (95% CI 10-34%). Success was defined as ≥16/ 39 patients ( > 40%) event-free at 12 months from enrollment. Secondary objectives included toxicity evaluation and dinutuximab pharmacokinetics (PK). Results: Forty-one patients were enrolled from Nov 2015 - Jan 2018. Thirty nine were eligible and evaluable (age 7-26 yr; median 15 yr). Data current to December 31, 2019 was used for analysis. Accrual rate was higher than expected (22.1 vs. 19.2 patients/ yr.) despite a concurrently open competing study. One of 136 administered therapy cycles met criteria for unacceptable toxicity when one patient receiving the 2-day schedule died after cycle 2 due to an unknown cause, attributed as probably related to protocol therapy. The protocol was revised to allow only the 4-day schedule. Other ≥ Grade 3 toxicities occurring in > 10 % participants were expected dinutuximab toxicities such as pain, diarrhea, hypoxia and hypotension. Dinutuximab did not demonstrate sufficient evidence of efficacy as 27/ 39 patients experienced an event for a DCR of 30.7% (95% CI 17- 47%). PK studies are pending and will be reported. Conclusions: Dinutuximab toxicity in adolescent and young adult OS patients was similar to younger patients. While GD2 remains a relevant target in OS, combination of dinutuximab with GM-CSF did not meet the targeted successful DCR in patients with completely resected tumor. Other strategies for targeting GD2 or dinituximab combination therapy may still be warranted. Clinical trial information: NCT02484443.

scholarly journals Management and Survival of Elderly and Very Elderly Patients with Ovarian Cancer: An Age-Stratified Study of 1123 Women from the FRANCOGYN Group

2020 ◽  
Vol 9 (5) ◽  
pp. 1451
Author(s):  
Yolaine Joueidi ◽  
Ludivine Dion ◽  
Sofiane Bendifallah ◽  
Camille Mimoun ◽  
Alexandre Bricou ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Elderly Patients ◽  
Elderly Women ◽  
Residual Disease ◽  
Univariate Analysis ◽  
Advanced Ovarian Cancer ◽  
The Elderly ◽  
Figo Stage ◽  
Very Elderly ◽  
Cancer Management

Elderly women with ovarian cancer are often undertreated due to a perception of frailty. We aimed to evaluate the management of young, elderly and very elderly patients and its impact on survival in a retrospective multicenter study of women with ovarian cancer between 2007 to 2015. We included 979 women: 615 women (62.8%) <65 years, 225 (22.6%) 65–74 years, and 139 (14.2%) ≥75 years. Women in the 65–74 years age group were more likely to have serous ovarian cancer (p = 0.048). Patients >65 years had more >IIa FIGO stage: 76% for <65 years, 84% for 65–74 years and 80% for ≥75 years (p = 0.033). Women ≥75 years had less standard procedures (40% (34/84) vs. 59% (104/177) for 65–74 years and 72% (384/530) for <65 years (p < 0.001). Only 9% (13/139) of women ≥75 years had an Aletti score >8 compared with 16% and 22% for the other groups (p < 0.001). More residual disease was found in the two older groups (30%, respectively) than the younger group (20%) (p < 0.05). Women ≥75 years had fewer neoadjuvant/adjuvant cycles than the young and elderly women: 23% ≥75 years received <6 cycles vs. 10% (p = 0.003). Univariate analysis for 3-year Overall Survival showed that age >65 years, FIGO III (HR = 3.702, 95%CI: 2.30–5.95) and IV (HR = 6.318, 95%CI: 3.70–10.77) (p < 0.001), residual disease (HR = 3.226, 95%CI: 2.51–4.15; p < 0.001) and lymph node metastasis (HR = 2.81, 95%CI: 1.91–4.12; p < 0.001) were associated with lower OS. Women >65 years are more likely to have incomplete surgery and more residual disease despite more advanced ovarian cancer. These elements are prognostic factors for women’s survival regardless of age. Specific trials in the elderly would produce evidence-based medicine and guidelines for ovarian cancer management in this population.

A phase IB study of ipilimumab with peginterferon alfa-2b in patients with unresectable melanoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9079-9079 ◽  
Author(s):  
Ragini Reiney Kudchadkar ◽  
Geoffrey Thomas Gibney ◽  
Jeffrey Weber ◽  
Ann Chen ◽  
Kim Smith ◽  
...  
Keyword(s):  
Small Population ◽  
Anticardiolipin Antibodies ◽  
Double Stranded Dna ◽  
Patient Decision ◽  
Grade 3 ◽  
Peginterferon Alfa ◽  
Male Subjects ◽  
Dose Reductions ◽  
Unacceptable Toxicity ◽  
Clinical Trial Information

9079 Background: Peginterferon alfa-2b (Sylatron) as adjuvant therapy has been shown to benefit patients with high-risk resected melanoma and some interferon studies have shown that the induction of autoantibodies may correlate with benefit. Ipilimumab (IPI, Yervoy) is a fully human anti-CTLA-4 antibody that induces autoimmune toxicity that in some cases appears to correlate with clinical benefit. This study was performed to assess whether ipilimumab can be safely administered with peginterferon alfa-2b. Methods: This study combined IPI at 3mg/kg every 3 weeks for 4 doses along with concurrent peginterferon alfa-2b at 3 mcg/kg weekly for up to 156 weeks or until disease progression, unacceptable toxicity or patient decision to discontinue. The study was designed to obtain toxicity, tolerability and autoimmune antibody data and to define a well-tolerated dose of the combination. Results: Median age was 61 with 9 female and 8 male subjects. There were 3 patients (pts) with partial responses, 1 stable disease, and 6 with progressive disease in 10 pts evaluable for response thus far. Six pts have not yet completed cycle 1 and therefore are not evaluable for response at the time of this publication but will be presented. One pt withdrew consent prior to finishing cycle 1. Toxicities from peginterferon alfa-2b 3mcg/kg were dose-limiting with 7 pts requiring dose reduction in peginterferon alfa-2b secondary to toxicity. The Grade 3 events leading to dose reductions were nausea and vomiting, leucopenia, dehydration, and hyponatremia. peginterferon alfa-2b was dose reduced to 2 mcg/kg weekly in future pts after these toxicities were noted. No Grade 3 or 4 toxicities attributable to ipilimumab have occurred thus far. No Grade 3 or 4 events have been noted to date in the10 pts initiated at 2 mcg/kg of peginterferon alfa-2b. There was no significant change in the presence autoantibodies (ANA, anti-double stranded DNA, antithyroglobulin, antimicrosomal antibodies, and anticardiolipin antibodies) between responders and non-responders in the evaluable pts. Conclusions: Peginterferon alfa-2b added to IPI results in an excellent response rate in this small population. Peginterferon alpha-2b at 2 mcg/kg weekly with IPI at 3 mg/kg every 3 weeks appears well-tolerated and the combination warrants further exploration. Clinical trial information: NCT01496807.

The Pentostatin, Cyclophosphamide, and Rituximab Regimen (PCR) Is Highly Active and Well Tolerated Regardless of Patient Age, Creatinine Clearance, and Performance Status: Analysis of a Multi-Center Phase II Trial.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 36-36 ◽  
Author(s):  
Tait D. Shanafelt ◽  
John C. Byrd ◽  
Susan M. Geyer ◽  
Debra Bowen ◽  
Betsy LaPlant ◽  
...  
Keyword(s):  
Renal Function ◽  
Elderly Patients ◽  
Creatinine Clearance ◽  
Performance Status ◽  
Infectious Complications ◽  
Hematologic Toxicity ◽  
Number Of Patients ◽  
Grade 3 ◽  
Number Of Cycles ◽  
Dose Delay

Abstract Background: CLL is a disease of the elderly and at least half of the patients requiring therapy are over age 70. While chemoimmunotherapy (CIT) has dramatically improved response rates in patients with CLL, some CIT regimens are not well tolerated by elderly patients. The MD Anderson group has reported that the fludarabine, cyclophosphamide, rituximab (FCR) regimen is not well tolerated in individuals ≥age 70 (Ferrajoli Leuk Lymph 46:S86). The German CLL Study Group has postulated that physiologic health is more important than chronologic age and have conducted a trial of FCR that permits enrollment of patients ≥age 70 provided they have a creatinine clearance (CrCl) ≥70 and good performance status (PS). While this approach expands the number of individuals who can receive CIT, it still excludes large percentages of CLL patients in need of treatment. Here, we examine how age, CrCl, and PS relate to the efficacy and tolerability of the pentostatin, cyclophosphamide, and rituximab (PCR) regimen. Methods: We treated 64 previously untreated CLL patients meeting NCI 96 criteria for treatment with pentostatin (2mg/m2), cyclophosphamide (600 mg/m2) and rituximab (375mg/m2) (Kay ASH 2006). All medications were administered on day 1 of every 3 week cycle with the intent of administering 6 cycles. We measured ECOG PS at study entry and used age, weight, and baseline creatinine to calculate the CrCl of all patients at study entry using the Cockroft-Gault equation. Results: Eighteen of 64 patients (28%) were ≥age 70. Although individuals ≥age 70 were more likely to have a dose delay of >1 week at some point during the trial (7% vs. 28%; p=0.03), there was no difference in the average number of cycles administered, the number of patients requiring dose reductions, or the number of patients with grade 3/4 hematologic toxicity, infectious complications, or other non-hematologic toxicity. No difference in OR (93% vs 83%; p=0.34) or CR (41% vs. 39%; p=0.86) was observed between patients <age 70 compared to those ≥70. We next evaluated whether CrCl related to the efficacy and tolerability of PCR. 25 patients (39%) had a CrCl<70, including 15 (23%) with a CrCl<60 and 5 (8%) with CrCl<50. Although individuals with CrCl<70 were more likely to have a dose reduction (5% vs. 24%; p=0.05), there was no difference in the average number of cycles administered, the number of patients requiring a dose delay, or the number of patients with grade 3/4 hematologic toxicity, infectious complications, or other non-hematologic toxicity. No difference in OR (89% vs 92%; p=1.0) or CR (45% vs. 36%; p=0.60) was observed between patients with CrCl≥70 and those with CrCl<70. We next evaluated how PS related to the efficacy and tolerability. 34 patients (53%) were PS 0 and 30 (47%) were PS≥1. This analysis suggested PCR was well tolerated among those with PS≥1. Again no difference in the OR or CR was observed between patients with PS 0 and those with PS≥1. Conclusions: In this phase II clinical trial, the PCR regimen was well tolerated by patients ≥age70, those with higher PS, and the 25 individuals with CrCl≤70 (range 34–67). The efficacy of PCR was also not significantly affected by age, renal function, or performance status. These findings suggest the PCR regimen may be superior to the FCR regimen for elderly patients and those with decreased renal function.

Phase Ib/II study of INNO-206 (EMCH-doxorubicin) in patients with soft tissue sarcoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10036-10036 ◽  
Author(s):  
Sant P. Chawla ◽  
Victoria S Chua ◽  
Andrew Hendifar ◽  
Doris Quon ◽  
Sandeep Nagre ◽  
...  
Keyword(s):  
Progressive Disease ◽  
Tumor Response ◽  
Acid Reflux ◽  
Hematological Toxicity ◽  
Cardiac Ultrasound ◽  
Standard Doxorubicin ◽  
Grade 3 ◽  
Dose Levels ◽  
Dose Limiting Toxicity ◽  
Unacceptable Toxicity

10036 Background: The safety and preliminary tumor response of a doxorubicin conjugate, INNO-206, was evaluated primarily in patients with metastatic STS who progressed on prior chemotherpy. INNO-206 consists of doxorubicin attached to an acid-sensitive linker that binds covalently to cysteine-34 in circulating albumin. Methods: INNO-206 was administered IV at doses of either 230, 350 and 450 mg/m2 (165, 260 and 325 mg/m2 dox. eq.) every 21 days for up to 8 consecutive cycles. Subsequent dose levels were administered if < 2/5 or 4/8 patients experienced a non-hematological dose-limiting toxicity during Cycle 1. Tumor response was monitored every other month and treatment continued until tumor progression or unacceptable toxicity. Standard safety monitoring was performed and cardiac function was followed periodically using MUGA or cardiac ultrasound. Results: As of January 11, 2012, 25 patients were entered in the study. 21/25 patients had STS of various types. Of the 5 patients treated at 230 mg/m2 INNO-206, 1 subject had grade 3 fatigue and acid reflux. Of the initial 5 patients entered at the 350 mg/m2 dose, no individuals experienced a grade 3 or 4 non-hematological toxicity during cycle 1. 2 patients treated at the 450 mg/m2 dose developed grade 3 oral mucositis during cycle 1. No patient exhibited cardiotoxicity as determined by MUGA or cardiac ultrasound. The MTD was determined to be 350 mg/m2 INNO-206 (260 mg/m2 dox.eq.). 15 more patients were entered at this dose (total of 20 patients). Of the 16 patients with STS, 3 objective partial responses (one of whom received prior doxorubicin) are ongoing as well as 10 patients with stable disease (range 2-7 months). 1 patient had progressive disease at the first evaluation. 2 patients died within the first cycle, one due to progressive disease and the other due to sepsis. Conclusions: INNO-206 is an active drug for the treatment of patients with advanced STS who have failed prior chemotherapy. Cumulative doses of 2000 mg/m2 of doxorubicin equivalents have been achieved, which is over 3 1/2 x the peak cumulative dose of standard doxorubicin. Adverse events are primarily hematological and no cardiotoxicity has been observed.

scholarly journals Real Life Use of Bendamustine in Elderly Patients with Lymphoid Neoplasia

2021 ◽  
Vol 11 (4) ◽  
pp. 249
Author(s):  
Irene Dogliotti ◽  
Simone Ragaini ◽  
Francesco Vassallo ◽  
Elia Boccellato ◽  
Gabriele De Luca ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Rating Scale ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Real Life ◽  
Lymphocytic Leukemia ◽  
Factors Affecting ◽  
Lymphoid Neoplasia ◽  
Baseline Factors ◽  
Grade 3

Background. Bendamustine is a cytotoxic alkylating drug with a broad range of indications as a single agent or in combination therapy in lymphoid neoplasia patients. However, its tolerability in elderly patients is still debated. Methods: An observational, retrospective study was carried out; patients with chronic lymphocytic leukemia (CLL) or lymphoma, aged ≥ 65 years old, treated with bendamustine-based regimens in first or subsequent lines between 2010 and 2020 were considered eligible. Results: Overall, 179 patients aged ≥ 65 years were enrolled, 53% between 71 and 79 years old. Cumulative Illness Rating Scale (CIRS) comorbidity score was ≥6 in 54% patients. Overall survival (OS) at 12 months was 95% (95% confidence interval [CI]: 90–97%); after a median follow up of 50 months, median OS was 84 months. The overall response rate was 87%, with 56% complete responses; the median time to progression (TTP) was 61 months. The baseline factors affecting OS by multivariable analysis were sex, histological diagnosis, renal function, and planned bendamustine dose, while only type of lymphoma and bendamustine dose impacted on TTP. Main adverse events were neutropenia (grade ≥ 3: 43%) and infections (any grade: 36%), with 17% of patients requiring hospital admission. Conclusions: The responses to bendamustine, as well as survival, are relevant even in advanced age patients, with a manageable incidence of acute toxicity.

scholarly journals A phase I study of combined trabectedin and pegylated liposomal doxorubicin therapy for advanced relapsed ovarian cancer

2021 ◽  
Author(s):  
Shunji Takahashi ◽  
Munetaka Takekuma ◽  
Kenji Tamura ◽  
Kazuhiro Takehara ◽  
Hiroyuki Nomura ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase I ◽  
Liposomal Doxorubicin ◽  
Advanced Ovarian Cancer ◽  
Pegylated Liposomal Doxorubicin ◽  
Japanese Patients ◽  
Pharmacokinetic Analysis ◽  
Dependent Manner ◽  
Drug Concentrations ◽  
Grade 3

Abstract Background Advanced relapsed ovarian cancer has a poor prognosis, and treatment options are limited. Methods This phase I trial investigated the dosage, safety, pharmacokinetics and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in Japanese patients with advanced relapsed ovarian, fallopian tube, or primary peritoneal cancer. Patients received trabectedin 0.9 or 1.1 mg/m2 immediately after PLD 30 mg/m2; both drugs were given by intravenous infusion. Treatment was repeated every 21 days until disease progression or unacceptable toxicity. The maximum tolerated dose (MTD) was determined in an initial dose escalation phase, and this was used in a subsequent safety assessment phase. Safety and tumor response were monitored throughout the trial, and drug concentrations for pharmacokinetic analysis were measured during cycle 1. Results Eighteen patients were included. The MTD of trabectedin was determined as 1.1 mg/m2. Gastrointestinal adverse events were experienced by all patients, but were mostly grade 1 or 2 in intensity. Most patients had grade ≥ 3 elevations in transaminase levels or grade ≥ 3 reductions in neutrophil count, but these events were generally manageable through dose reduction and/or supportive therapies, as appropriate. There were no deaths during the trial. Trabectedin exposure increased in a dose-dependent manner. The overall response rate was 27.8%. Conclusions Trabectedin, in combination with PLD, may have clinical benefits in Japanese patients with relapsed advanced ovarian cancer. The recommended dosage of trabectedin for further study in this population is 1.1 mg/m2 once every 21 days. Clinical trial registration number: JapicCTI-163164

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