A multicentre phase 2 study of carboplatin (C) plus pegylated liposomal doxorubicin (PLD) as first-line chemotherapy for patients (pts) with advanced or recurrent endometrial carcinoma (AEC): The END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer) Group

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5041-5041 ◽  
Author(s):  
D. Lorusso ◽  
S. Pignata ◽  
G. Scambia ◽  
V. Zagonel ◽  
N. Riva ◽  
...  
Keyword(s):  
Liver Toxicity ◽  
Objective Response ◽  
Pegylated Liposomal Doxorubicin ◽  
Stage Iv ◽  
Type I ◽  
Phase 2 ◽  
First Line ◽  
Multicentre Phase ◽  
Phase 2 Study ◽  
Line Chemotherapy

5041 Background: Anthracyclines and platinum derivates are active drugs for pts with AEC, but new schedules with higher efficacy and better tolerability are needed. A prospective phase 2 study was conducted to describe tolerability and activity of C + PLD in pts with AEC. Methods: Pts with chemo-naïve AEC, PS ≤2, aged less than 75 years and with at least one measurable lesion were eligible. Treatment was C (AUC 5) + PLD (40 mg/m2) on day 1 every 4 weeks, up to 6 cycles. A single-stage design was applied. With objective response as primary endpoint, type I error = 0.05 and II error = 0.10, p0 = 0.20, p1= 0.40, 42 patients were needed, with at least 13 objective responses to define the treatment active. Response was assessed by RECIST and toxicity was coded with NCI-CTC. Results: From November 2002 to July 2005, 42 pts were enrolled at 5 Institutions. Median age was 64 years (31–74). PS was 0/1/2 in 28/13/1 pts, respectively. 62% of pts were stage IV. Out of 40 pts out of treatment, 3 complete (7.5%) and 20 partial responses (50%) have been already observed, for an overall response rate of 57.5% (95% exact CI: 40.9–73.0). One death potentially related to treatment was recorded (death at home for unknown reasons after 6th cycle). Other relevant toxicities (% of pts) were g3/4 neutropenia 30%/15%, febrile neutropenia 5%, g3/4 thrombocytopenia pts 17.5%/5%, g3/4 anemia 32.5%/5%, g3 heart rhythm 1 pt, g2 liver toxicity 1pt. Skin toxicity was mild: g1 12.5%, g2 7.5%, g3 5%. Hair loss: complete 1 pt, partial 12.5%. Conclusions: The combination of C and PLD shows a good activity and a favourable toxicity profile in first-line chemotherapy of pts with AEC, deserving further studies in this setting. No significant financial relationships to disclose.

scholarly journals Biweekly Oxaliplatin Plus S1 (SOX) As First Line Therapy For Advanced Or Metastatic Gastric Or Gastroesophageal Junction (G/GEJ) Caner In Chinese Elderly Patients: An Open-Label, Single-Arm, Phase 2 Study.

2021 ◽  
Author(s):  
Zhichao Jiang ◽  
Aiping Zhou ◽  
Yongkun Sun ◽  
Wen Zhang
Keyword(s):  
Cancer Patients ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Cancer Center ◽  
Phase 2 ◽  
First Line ◽  
Open Label ◽  
Weekly Chemotherapy ◽  
Phase 2 Study ◽  
Grade 3

Abstract Background: SOX (oxaliplatin and S1 every 3 weeks) is one of the most common used first line chemotherapy for advanced or metastatic G/GEJ cancer in Asia, but with significant hematological and neurological toxicity. In China, the majority of gastric cancer patients are the middle-aged and elderly with dissatisfactory tolerance to 3-weekly chemotherapy. Therefore, we aimed to assess efficacy and safety of biweekly SOX as first line treatment in patients 60 years old or older with advanced G/GEJ cancer in a single arm phase 2 study. Methods: Oxaliplatin was administered intravenously on day 1 at 85 mg/m2. S-1 was given at 80, 100, 120 mg/day depending on body surface area of <1.25 m2, 1.25 to <1.5 m2, or ≥1.5 m2 two times daily on days 1-10, every 2 weeks. Eligible patients were aged 60 years old or older with histological or cytological diagnosis of advanced G/GEJ adenocarcinoma, had measurable disease according to the RECIST v 1.1 without previous treatment. The primary endpoint was objective response rate (ORR), and the secondary endpoints included progression free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR) and safety. Results: Between May 2016 and Sep 2018, 42 patients were enrolled. Median follow-up time was 43.6 months. ORR and DCR were 52.4% and 85.7%, respectively. Median PFS was 4.6 months (95%CI 2.486-6.714). Median OS was 11.1 months (95%CI 8.001-14.199). The most common treatment-related adverse events (TRAEs) of any grade were thrombocytopenia (59.5%), neutropenia (57.1%), appetite loss (57.1%) and nausea (54.8%). Only two patients respectively suffered from grade 3 treatment-related neutropenia (1 patient, [2.4%]) and diarrhea (1 patient, [2.4%]). No other grade 3 or worse TRAEs occurred. Conclusions: First line biweekly SOX showed promising PFS and OS with a remarkable tolerance in advanced G/GEJ cancer patients 60 years old or older preliminary worth further evaluation.Trial registration: ClinicalTrials.gov ID: NCT04694404 (5/1/2021). This study was approved by the Ethical Committee of National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, (17-048/1303).

Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for patients with immunomodulatory advanced triple-negative breast cancer (FUTURE-C-PLUS): A prospective, single-arm, phase 2 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1007-1007
Author(s):  
Li Chen ◽  
Shao Zhimin ◽  
Zhonghua Wang ◽  
Wentao Yang ◽  
Yizhou Jiang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adverse Events ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Objective Response ◽  
Antiangiogenic Agents ◽  
Phase 2 ◽  
First Line ◽  
Phase 2 Study ◽  
Biomarker Analysis

1007 Background: Camrelizumab (anti-PD-1 antibody) and nab-paclitaxel (nab-P) have demonstrated promising anti-tumour activity in patients with immunomodulatory (IM) subtype metastatic triple negative breast cancer (TNBC), with 52.6% of ORR observed in heavily pretreated patients in our previous umbrella trial (FUTURE). As antiangiogenic agents were known to enhance the response to immune checkpoint inhibitors, we assessed the efficacy and safety of novel triplet combination of famitinib (tyrosine kinase inhibitor targeting VEGFR-2, PDGFR and c-kit), camrelizumab and nab-paclitaxel in patients with IM subtype advanced TNBC. Methods: In this prospective, single-arm, phase 2 study, eligible patients were 18-70 years and had treatment-naive IM subtype unresectable locally advanced or metastatic TNBC. IM subtype was defined as CD8+ by immunohistochemistry. Eligible patients received camrelizumab (200 mg iv, d1, 15, q4w) with nab-P (100 mg/m2 iv, d1, 8, 15, q4w) and famitinib (20 mg po qd, d1-28, q4w). Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. In the absence of intolerable toxicity, nab-P was to be administered for a minimum of 6 cycles. Primary endpoint was objective response rate according to RECIST v1.1. We explored the predictive biomarkers using targeted sequencing with a 484-gene panel. Results: From Oct 2019 to Oct 2020, 48 patients were enrolled. Confirmed objective responses were achieved in 39 (81.3%; 95% CI 70.2%-92.3%) of 48 patients in the intention-to-treat population and in 39 (84.8%; 95% CI 74.4%-95.2%) of 46 patients in the per-protocol population. Median time to response was 1.8 months (95% CI 1.8-2.0 months). With a median follow-up of 9.0 months, progression-free survival (PFS) and duration of response data were not mature. Thirty patients (62.5%) are still on the study treatment. The 9-month PFS rate was 60.2% (95% CI, 43.2% to 77.3%). Grade 3 or 4 adverse events were neutropenia (33.3%), anaemia (10.4%), febrile neutropenia (10.4%), thrombocytopenia (8.3%), hypertension (4.2%), hypothyroidism (4.2%), proteinuria (2.1%), septicemia (2.1%) and immune related myocarditis (2.1%). Adverse events that led to the discontinuation of any agent occurred in 6.3% of the patients. Two patients had treatment-related serious adverse events. No treatment-related deaths were reported. Biomarker analysis showed that somatic mutations of GSK3A may have the potential to predict immunotherapy response. Conclusions: Addition of famitinib to camrelizumab and nab-paclitaxel showed promising antitumour activity as first-line therapy with manageable toxicity profile for IM subtype advanced TNBC patients. Results from ongoing randomized controlled trial FUTURE-SUPER (NCT 04395989) are eagerly awaited. Clinical trial information: NCT04129996 .

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