scholarly journals Afatinib vs erlotinib as second-line therapy of patients with advanced SCC of the lung following platinum-based chemotherapy: OS analysis from the global phase III trial LUX-Lung 8 (LL8)

2015 ◽  
Vol 26 ◽  
pp. vi73
Author(s):  
A. Morabito ◽  
A.A. Brandes ◽  
A. Sibau ◽  
L. Ciuffreda ◽  
A. Favaretto ◽  
...  
Keyword(s):  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
Line Therapy ◽  
Platinum Based Chemotherapy

NET-02: A multi-center, randomised, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4158-TPS4158
Author(s):  
Mairead Geraldine McNamara ◽  
Jayne Swain ◽  
Zoe Craig ◽  
Jonathan Wadsley ◽  
Nicholas Reed ◽  
...  
Keyword(s):  
Phase Ii Trial ◽  
Phase Iii ◽  
High Grade ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
Line Therapy ◽  
Platinum Based Chemotherapy ◽  
Therapy Option

TPS4158 Background: The prognosis for pts with PD-EP-NEC is poor. First-line treatment for advanced disease is etoposide/platinum-based chemotherapy, analogous to that of high grade lung NEC, with no standard second-line treatment, and is an area of unmet need. Methods: This is a multi-centre, randomised, phase II trial of nal-IRI; 80mg/m2 intravenously (IV) over 90 mins, prior to 5-FU; 2400 mg/m2 infusion over 46 hrs and folinic acid, Q14 days, or docetaxel; 75mg/m2 IV over 60 mins, Q21 days, as second-line therapy in pts with progressive PD-EP-NEC (Ki-67 > 20%), with the overall aim of selecting a treatment for continuation to a phase III trial. The standard arm is that used in high-grade lung NEC, of which docetaxel is a second-line therapy option (NCCN guidelines) and combination regimens such as Irinotecan/5-FU are a second-line therapy option currently used without trial evidence for this subset of pts. Pts must have had prior treatment with first-line platinum-based chemotherapy, have documented disease progression and have an ECOG performance status of ≤2. This study plans to recruit 102 pts from 16 UK centres (over 37 mths). Primary endpoint is 6-mth progression-free survival (PFS) rate; trial is designed to have an 80% chance of demonstrating that the one-sided 95% confidence interval of the 6 mth PFS rate excludes 15%, if the true rate is at least 30%, where 30% is the required level of efficacy, and a rate of < 15% would give grounds for rejection. If both treatment arms exceed the required level of efficacy to warrant further evaluation in a phase III trial, treatment with the higher PFS rate at 6 mths will be selected. Secondary endpoints include overall survival, objective response rate, toxicity, quality of life, serum neuron-specific enolase. Exploratory endpoints include quantification of circulating tumour cells (CTCs), circulating tumour deoxyribonucleic acid (ctDNA) and molecular profiling of CTCs, ctDNA and tumour tissue, and generation of CTC-derived xenografts. This trial is open and has enrolled 6 pts at time of submission. Clinical trial information: 10996604.

Assessment of ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients (pts) with advanced HER2-negative gastric or gastroesophageal junction cancers: The ARMANI phase III trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4151-TPS4151 ◽  
Author(s):  
Federica Morano ◽  
Monica Niger ◽  
Salvatore Corallo ◽  
Sara Lonardi ◽  
Stefano Tamberi ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
First Line Therapy ◽  
Line Therapy ◽  
Her 2

TPS4151 Background: Platinum/fluoropyrimidine regimens are the backbone of first-line therapy for advanced gastric cancer (AGC). The optimal duration of first-line therapy is still unknown and its continuation until disease progression represents the standard. However this strategy is often associated with cumulative toxicity and rapid development of drug resistance. Moreover, only 40% of AGC pts are eligible for second-line treatment. This study aims at assessing whether switch maintenance to ramucirumab plus paclitaxel will extend the progression-free survival (PFS) of subjects with HER-2 negative AGC who have not progressed after a first-line with a platinum/fluoropyrimidine regimen. The hypothesis is that the early administration of an active, non-cross resistant regimen may delay disease progression and, consequently, improve pts’ quality of life. This strategy may also rescue all those subjects that become ineligible for a second-line therapy due to the rapid clinical deterioration. Methods: This is a randomized, open-label, multicenter, phase III trial. Eligibility criteria are: unresectable/metastatic HER-2 negative AGC or gastroesophageal junction (GEJ) cancer; ECOG PS 0-1; measurable and/or evaluable disease by RECIST v1.1; no progression after 3 months of therapy with either FOLFOX4, mFOLFOX6 or XELOX . The primary endpoint is to compare PFS of pts in ARM A (continuation of the same first-line therapy with oxaliplatin/fluoropyrimidine) versus ARM B (switch maintenance to ramucirumab and placlitaxel). Secondary endpoints are: overall survival, time-to-treatment failure, overall response rate, duration of response, percentage of pts receiving a second-line therapy per treatment arm, safety and quality of life. Exploratory analyses to identify primary resistance and prognosis biomarkers are planned, including Next-Generation Sequencing (NGS) on archival tumor tissues. The ARMANI study is sponsored by the Fondazione IRCCS Istituto Nazionale dei Tumori and it is ongoing at 29 Italian centers with a planned population of 280 pts. Clinical trial information: NCT02934464.

Axitinib versus sorafenib as second‑line therapy in Asian patients with metastatic renal cell carcinoma (mRCC): Results from a registrational study.

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA4537-LBA4537
Author(s):  
Shukui Qin ◽  
Feng Bi ◽  
Ying Cheng ◽  
Jun Guo ◽  
Xiu Bao Ren ◽  
...  
Keyword(s):  
Objective Response ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
Asian Patients ◽  
Line Therapy ◽  
Independent Review ◽  
Previously Treated ◽  
Ecog Ps

LBA4537 Notice of Retraction: "Axitinib versus sorafenib as second-line therapy in Asian patients with metastatic renal cell carcinoma (mRCC): Results from a registrational study." Abstract LBA4537, published in the 2012 Annual Meeting Proceedings Part II, a supplement to the Journal of Clinical Oncology, has been retracted by Shukui Qin, MD, on behalf of all authors of the abstract. The adjudication portion of the Independent Review Committee (IRC) tumor assessments were incomplete for some of the ongoing patients in the study reported in the abstract and the adjudication could not be completed in time for presentation at the 2012 ASCO Annual Meeting. Background: An earlier phase III trial in 723 patients with previously treated mRCC demonstrated significantly longer progression-free survival (PFS) for axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors, compared with sorafenib. We conducted a multicenter, randomized, open-label trial to estimate PFS for axitinib and sorafenib in 204 Asian patients with previously treated mRCC. Methods: Patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 and measurable, clear-cell, mRCC that had progressed after 1 prior first-line systemic regimen (sunitinib or cytokines) were randomly assigned (2:1) to 28-day cycles of axitinib 5 mg twice daily (BID) or sorafenib 400 mg BID. Axitinib dose reductions and stepwise dose titrations to 7 mg BID and then 10 mg BID, as tolerated, were allowed; sorafenib dose reductions to 400 mg daily or every other day were also allowed. Primary endpoint was PFS per independent review committee. Results: Patients were stratified by ECOG PS and prior first-line systemic therapy: 135 received axitinib and 69 received sorafenib.Baseline patient characteristics included median age 56 years, 70% male, 99% Asian, and 63% ECOG PS 0. Prior therapy included sunitinib (45%) or cytokines (53%). Median PFS was 6.4 months (95% confidence interval: 4.6, 8.3) with axitinib and 4.8 months (2.8, 6.5) with sorafenib. Objective response rates were 23.7% with axitinib and 10.1% with sorafenib. All-grade adverse events in ≥15% of patients (axitinib, sorafenib) included hypertension (50%, 36%), weight decreased (37%, 33%), diarrhea (34%, 30%), hand-foot syndrome (32%, 57%), decreased appetite (30%, 20%), hypothyroidism (28%, 23%), fatigue (27%, 23%), proteinuria (21%, 20%), dysphonia (19%, 9%), cough (16%, 16%), rash (15%, 28%), pyrexia (7%, 16%), alopecia (3%, 22%). Conclusions: Asian patients receiving axitinib as second-line therapy for mRCC had a similar PFS and objective response rate as in a previous global phase III trial, with an acceptable safety profile.

A multinational, randomized, phase III trial of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab as second-line therapy for metastatic colorectal cancer: Safety analysis of Asian XELIRI project (AXEPT).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 681-681
Author(s):  
Masato Nakamura ◽  
Tae Won Kim ◽  
Rui-hua Xu ◽  
Young Suk Park ◽  
Yong Sang Hong ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Safety Analysis ◽  
Phase Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Phase Iii Trial ◽  
Line Therapy ◽  
Significant Difference ◽  
Grade 3

681 Background: Several studies have shown that capecitabine plus irinotecan (XELIRI) has promising efficacy and safety in patients with metastatic colorectal cancer. AXEPT is a non-inferiority, phase III comparison of XELIRI with or without bevacizumab vs 5-fluorouracil/folinic acid plus irinotecan (FOLFIRI) with or without bevacizumab as second-line therapy in patients with metastatic colorectal cancer. Methods: We undertook an open-label, non-inferiority, randomized phase III trial in South Korea, China and Japan. Patients were randomized 1:1 to XELIRI (irinotecan 200 mg/m2 on day 1 plus capecitabine 800 mg/m2 twice daily for 2 weeks in a 3-week cycle) with or without bevacizumab 7.5 mg/kg or FOLFIRI with or without bevacizumab. The primary endpoint was overall survival. Results: From December 2013 to August 2015, 650 patients were enrolled and 625 (311 in FOLFIRI and 314 in XELIRI) were included to safety analysis at the cutoff dates on August 31, 2016. Patient baseline characteristics including KRAS status and UGT1A1 gene polymorphism were similar between the two treatment arms. Prior chemotherapy with oxaliplatin was given to 97.4% in both arms. The overall incidence of grade 3-4 toxicity was 73% in FOLFIRI arm and 53.2% in XELIRI arm. Whereas FOLFIRI was associated with more grade 3-4 neutropenia (43.7% vs 16.2%), leucopenia (13.5% vs 7.3%) and all grades anemia (80.4% vs 69.4%) than XELIRI, XELIRI was associated with more all grades hand-foot syndrome (34.1% vs 14.8%) and grade 3-4 diarrhea (7.0% vs 3.2%). There was no significant difference in febrile neutropenia (4.2% in FOLFIRI and 2.9% in XELIRI). The addition of bevacizumab did not alter safety profiles between XELIRI and FOLFIRI. There was a treatment-related death in FOLFIRI arm (0.3%). Conclusions: Both FOLFIRI and XELIRI were safe and well tolerated, though there were differences in the rates and toxicity profiles at which adverse events occur. Clinical trial information: NCT01996306. UMIN000012263.

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