Prospective observational cohort study of second-line chemotherapy administration after first-line platinum-based chemotherapy for patients with advanced NSCLC in Japan (SAPPHIRE study).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8058-8058
Author(s):  
Kiyotaka Yoh ◽  
Yasushi Goto ◽  
Yoichi Naito ◽  
Kazuma Kishi ◽  
Yasuo Ohashi ◽  
...  
Keyword(s):  
Observational Study ◽  
Maintenance Therapy ◽  
Disease Progression ◽  
Advanced Nsclc ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Platinum Based Chemotherapy ◽  
Line Chemotherapy

8058 Background: Maintenance therapy after first-line platinum-based chemotherapy (first-CT) is reported to be beneficial to patients with advanced non-small cell lung cancer (NSCLC). However, its impact on overall survival appears to be marginal or negligible, if those without maintenance receive active second-line chemotherapy (second-CT), which is initiated at disease progression. The purpose of this study is to investigate the proportion of second-CT administration after first-CT for patients with advanced NSCLC. Methods: From April 2010 to September 2011, 865 patients with advanced NSCLC who were initiated on first-CT at 30 institutions in Japan were enrolled in this prospective observational study. Baseline characteristics, regimens and responses to first-CT, whether or not they received second-CT, and if not, reasons for non-administration were recorded. This report describes from patients with at least 6 months of follow up. This study was supported by the Public Health Research Center Foundation CSPOR. Results: A total of 865 eligible patients with advanced NSCLC provided patient characteristics and details of first-CT. Of all patients, 70% had adenocarcinoma, 20% had squamous cell carcinoma, and 10% were positive for the EGFR mutation. At this data cut off, 225 patients were excluded from the analysis due to disease progression and loss of follow-up during first-CT, and 194 (22%) patients received maintenance therapy after first-CT. Among the 508 patients who were followed up for at least 6 months, 131 patients (26%) could not receive second-CT; the reasons were as follows: declined PS, 79 (60%); patient refusal, 28 (21%); death of any cause, 6 (5%); others, 18 (14%). Conclusions: Preliminary results of this large observational study in Japan suggested that around 20% of patients missed an opportunity to receive appropriate second-CT despite the follow-up of advanced NSCLC patients after first-CT. Further investigation is needed to elucidate the selection criteria of patients that may benefit the most from maintenance therapy, not second-CT at disease progression.

A phase II trial of weekly docetaxel for second-line treatment of urothelial carcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15613-e15613
Author(s):  
Young Saing Kim ◽  
Moon Ki Choi ◽  
Jung Yong Hong ◽  
Chi Hoon Maeng ◽  
Soonil Lee ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Objective Response ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Weekly Docetaxel ◽  
Platinum Based Chemotherapy ◽  
Line Chemotherapy

e15613 Background: Despite high response rates (RRs) with first-line platinum-based chemotherapy in advanced urothelial carcinoma (UCC), treatment after first-line failure remains unclear. The present multi-center phase II trial evaluated the tolerability and efficacy of weekly docetaxel as second-line chemotherapy for UCC. Methods: Between Aug 2010 and Sep 2012, 31 patients with measurable UCC, progressive after one prior platinum-based chemotherapy for advanced disease, were treated with docetaxel 30 mg/m2 on days 1 and 8. Treatment was repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoints were the RR, progression-free survival (PFS), and safety. To detect a 20% difference in RR (6% vs. 26%), 28 eligible patients were required. Results: All 31 patients were previously treated with gemcitabine/platinum and had Bellmunt risk of one or more. The patients’ median age was 64 years (range, 40 to 79) and 31 (100%) patients had an ECOG performance status of 1. A total of 106 (median, 2; range, 1 to 16) chemotherapy cycles were delivered. Although fatigue (13%) and anorexia (6%) were the most frequently observed grade 3 or 4 toxicities, safety profiles were generally mild and manageable. One patient developed prolonged thrombocytopenia which led to treatment discontinuation but was resolved thereafter. In an intent-to-treat analysis, two (6%) patients achieved objective response, which maintained for 3.0 to 7.8 months. Eight patients experienced disease stabilization, resulting in a disease control rate of 32%. The median PFS and overall survival were 1.4 (95% CI, 1.3 to 1.6) and 9.6 (95% CI, 7.8 to 11.4) months, respectively. Conclusions: Second-line chemotherapy with weekly docetaxel was well tolerated but demonstrated modest antitumor activity in patient with advanced UCC who had progression after first-line platinum-containing regimen and poor prognostic factors. Clinical trial information: NCT01711112.

Trastuzumab beyond progression in patients with HER2-positive advanced gastric adenocarcinoma: A multicenter AGEO study.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 94-94 ◽  
Author(s):  
Juliette Palle ◽  
David Tougeron ◽  
Astrid Pozet ◽  
Emilie Soularue ◽  
Pascal Artru ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Univariate Analysis ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Her2 Positive ◽  
Second Line Chemotherapy ◽  
Platinum Based Chemotherapy ◽  
Line Chemotherapy

94 Background: Trastuzumab in combination with platinum-based chemotherapy is the standard first line regimen in HER2 positive advanced gastric cancer. However, there is no data concerning continuation of trastuzumab beyond first line progression. Methods: This retrospective multicenter study include all consecutive patients with HER2 + advanced gastric or gastro-esophageal junction (GEJ) adenocarcinoma who received after progression of trastuzumab plus platinum-based chemotherapy, a second line chemotherapy with irinotecan, taxane or platinum salt, with or without trastuzumab. The prognostic variables with P values ≤0.10 in univariate analysis were eligible for the Cox multivariable regression model. Results: From August 2007 to March 2015, 104 patients were included (median age, 60.8 years; male, 78.8%; PS 0-1, 71.2%) with advanced (metastatic : 99%) gastric (45.2%) or GEJ (54.8%) cancer. All patients had received first line treatment based on trastuzumab plus fluoropyrimidine and cisplatin (n=54; 51.9%) or oxaliplatin (n=50; 48.1%). As second line chemotherapy, 67 patients (64.4%) received FOLFIRI regimen, including 19 who have continued trastuzumab; 23 patients (22.1%) received a taxane regimen (paclitaxel or docetaxel), including 12 with trastuzumab; and 14 patients (13.5%) received a platinum-based chemotherapy (different from that used in first-line), including 8 with trastuzumab. When considering all regimens of second-line chemotherapy, continuation (n=39) versus discontinuation (n=65) of trastuzumab was significantly associated with an increase on PFS (4.4 vs 2.3 months; p=0.002) and OS (12.6 vs 6.1 months; p=0.001). In multivariate Cox model (including ECOG PS, tumor grade, number of metastatic site, and second-line treatment), continuation of trastuzumab was significantly associated with longer PFS (HR=0.56; 95%CI [0.35-0.89]; p=0.01) and OS (HR=0.47; 95%CI [0.28-0.79]; p=0.004). Conclusions: This study suggests that maintenance of trastuzumab plus second line chemotherapy beyond disease progression has clinical benefit in patients with HER2 positive advanced gastric cancer. These results deserve a prospective randomized validation.

Outcome of Transplant-Eligible Patients with Hodgkin Lymphoma with An Inadequate Response to Second Line Chemotherapy with Gemcitabine, Dexamethasone, Cisplatin (GDP).

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2179-2179
Author(s):  
Tara Seshadri ◽  
Christine Massey ◽  
Noemi Puig ◽  
Armand Keating ◽  
Michael Crump ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Salvage Chemotherapy ◽  
Inadequate Response ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Disease Characteristics ◽  
Mass Size ◽  
Line Chemotherapy

Abstract Introduction: Standard practice for patients (pts) with Hodgkin Lymphoma (HL) who relapse or are refractory to primary therapy is second line chemotherapy followed by an autologous hematopoietic cell transplant (AHCT) in those who demonstrate chemotherapysensitive disease. Management of pts who achieve less than a partial remission (PR) to first line salvage chemotherapy is unclear. We evaluated the utility of further chemotherapy in pts unresponsive to GDP and to determine transplant outcomes of pts with stable disease (SD). Methods: This was a retrospective, single centre study of 118 pts from 2001–2008 with refractory/relapsed HL after ABVD or equivalent chemotherapy who were eligible for AHCT and received GDP as first line salvage chemotherapy. Patients undergoing AHCT had progenitor cells mobilized with cyclophosphamide (2g/m2 D1), etoposide (200mg/ m2 D1–3) and G-CSF. Intensive therapy consisted of etoposide 60mg/kg and melphalan 180mg/m2. Involved field radiation was given after AHCT to disease sites > 5cm. Response assessment prior to AHCT was performed using CT +/−gallium scan. Patients achieving PR or complete remission (CR) to GDP proceeded to AHCT. Pts with progressive disease (PD) on GDP were offered second line salvage chemotherapy with miniBEAM (MB; melphalan, etoposide, cytarabine, BCNU). Patients with SD post GDP were generally given further MB if residual mass was >5cm or if they remained gallium avid. Results: Median age was 38, (range 18–65), 42% were female, 80% had nodular sclerosis HL. At diagnosis, 21% had limited stage (1A/2A); 29% received radiotherapy. At relapse/ progression 36% had limited stage; 25% had B symptoms; 39% had primary refractory disease; median largest mass size was 4cm (range 1–12cm). Median follow up for transplanted (n=110) and non-transplanted (n=8) pts was 25.2 and 19 months, respectively. Response rate (PR+CR) to GDP chemotherapy was 75% (88/118). Response to GDP was unknown in 1 pt. 21 patients had SD and 8 had PD. 8 pts with SD post-GDP received MB resulting in 1 PR, 4 SD (1 gallium avid) and 3 PD. Eight pts with PD post-GDP received MB resulting in 4 PR, 1 SD (gallium avid) and 3 PD. Of the 16 MB pts, 8 responded adequately (PR or SD and gallium negative) and proceeded to AHCT. Median PFS for these 8 transplanted pts was 3.5 months (range 1–23), 2 year PFS was 23%. Of the 16 pts who received MB, only 3 (19%) remain in remission, 2 with less than 6 months follow up. We compared the disease characteristics (age, gender, mass size, stage, B symptoms, time to relapse) at first relapse/progression between the pts in SD transplanted after GDP alone to the 8 pts transplanted after MB. Patients receiving MB and AHCT were more likely to have B symptoms at relapse compared to pts with SD transplanted after GDP alone, p=0.048). For pts undergoing AHCT after GDP alone, 2 year PFS for those achieving PR/CR (n=88) to GDP compared to those only achieving SD (n=13) was similar − 69% for both groups (95%CI 59–81% for PR/CR and 48–99% for SD). No difference in disease characteristics at relapse was noted between the two groups. Conclusion: Selected patients (i.e. those with low bulk who are gallium negative) transplanted in SD after GDP have a comparable outcome to those transplanted in PR/CR. Patients who require additional therapy to achieve disease control prior to AHCT have a high relapse rate despite aggressive treatment. Additional studies evaluating functional imaging to direct further therapy and novel treatment strategies for pts with an inadequate response to chemotherapy pre-AHCT are warranted.

Elderly and younger patients with non-small cell lung cancer (NSCLC) derive similar benefit from second-line chemotherapy: A retrospective subset analysis of second-line chemotherapy trials conducted from the Hellenic Cooperative Research Group (HORG).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7564-7564
Author(s):  
Sofia Agelaki ◽  
Dora Hatzidaki ◽  
Lampros Vamvakas ◽  
Athanasios G. Pallis ◽  
Athanasios Karampeazis ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Second Line ◽  
Cooperative Research ◽  
First Line ◽  
Second Line Therapy ◽  
Younger Patients ◽  
Second Line Chemotherapy ◽  
Line Therapy ◽  
Significant Difference ◽  
Line Chemotherapy

7564 Background: Elderly patients (pts) achieve a similar survival benefit, with acceptable toxicity, from first-line chemotherapy for the treatment of advanced NSCLC compared with their younger counterparts. There have been no second-line trials specifically designed for elderly pts and few data exist on the efficacy and tolerability of second-line therapy in this population. Moreover, little if any information exists on the frequency of administration of second-line chemotherapy in these pts. Methods: The files of 2004 pts with advanced NSCLC enrolled into first-line chemotherapy trials performed by HORG from 1995 to 2007 were reviewed. A total of 600 pts who received second-line chemotherapy within the context of clinical trials were identified. Patients’ data were analysed for efficacy and toxicity according to age. Results: Second-line chemotherapy was administered in 24% and 34% of pts ≥65 and <65 years old after failure of prior therapy (p=0.0001). A total of 219 (24.8%) of 600 pts who received second-line treatment were ≥65 years old (median age 70 yrs, range 65-82). Response rates to second-line therapy were 11.9% for older pts compared to 12.3% for younger pts (p=ns). TTP was 2.8 and 3.1 months for older and younger pts, respectively (p=ns). Elderly pts receiving second-line chemotherapy had a median survival of 7.7 months compared with 8.2 months for younger pts (p=ns). Similar rates of haematological and non-haematological toxicities were encountered between the two groups. Conclusions: The participation of elderly pts to second-line chemotherapy trials was lower compared to younger patients. There was no significant difference in outcome or toxicity between elderly and younger pts. For elderly pts with advanced NSCLC and good performance status, second-line chemotherapy is appropriate. However, specific second-line trials in older pts are required since those included in the current analysis were probably highly selected to fit the inclusion criteria.

Optimal indications for second-line chemotherapy in advanced gastric cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 105-105
Author(s):  
Hiroko Hasegawa ◽  
Kazumasa Fujitani ◽  
Shoichi Nakazuru ◽  
Motohiro Hirao ◽  
Eiji Mita ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Prognostic Factors ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Clinicopathological Variables ◽  
Line Chemotherapy

105 Background: It remains uncertain whether every patient with advanced gastric cancer (AGC) who progresses after first-line chemotherapy should receive second-line chemotherapy. We conducted the present study to identify the optimal indications for second-line chemotherapy. Methods: In this retrospective study, 101 patients were included in univariate and multivariate analyses to identify clinicopathological variables independently associated with longer survival post progression (SPP), defined as the time from recognition of disease progression on first-line chemotherapy to death from any cause or last follow-up. Results: Median SPP of all patients was 340 days. On multivariate analysis, both performance status (PS) 2 (hazard ratio (HR), 14.234; 95% confidence interval (CI), 2.766–73.258), serum albumin (Alb) level < 3.5 g/dl (HR, 2.088; 95% CI, 1.047–4.060) at initiation of second-line chemotherapy, and time to progression (TTP) < 170 days on first-line chemotherapy (HR, 2.497; 95% CI, 1.227–5.083) were identified as independent prognostic factors for shorter SPP. Median SPP was 496, 375, and 232 days in patients with 0, 1, and 2 of these 3 negative prognostic factors, respectively (p = 0.0002). Conclusions: The present study suggests that second-line chemotherapy would be less beneficial in patients with 2 or more of the following 3 negative prognostic factors: PS 2, Alb < 3.5 g/dl at initiation of second-line chemotherapy, and TTP < 170 days on first-line chemotherapy.

Second-line chemotherapy in advanced pancreatic cancer: A retrospective, single-center analysis

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15187-15187 ◽  
Author(s):  
T. Herrmann ◽  
D. Jaeger ◽  
W. Stremmel ◽  
C. Herrmann
Keyword(s):  
Pancreatic Cancer ◽  
Disease Progression ◽  
Stable Disease ◽  
Partial Remission ◽  
Advanced Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

15187 Background: Patients with advanced pancreatic cancer profit from palliative chemotherapy. The role of second-line chemotherapy is not yet established. Methods: We performed a retrospective analysis in 98 patients who were treated at our department from 1/2004–6/2006 due to locally advanced or metastatic adenocarcinoma of the pancreas. Results: At the time of analysis 67 patients had died (median overall survival 9 months), 31 patients are still alive (median follow up 9 months). 12 patients were initially treated with radiochemotherapy. 86 patients received systemic chemotherapy; 43 of these patients were treated with second-line chemotherapy after disease progression. OS was significantly longer in patients who received second-line chemotherapy (10 months versus 5.0 months, p=0.023). Response to second-line chemotherapy was partial remission in 2 patients (4.6 %), stable disease in 18 patients (44.8 %), and progressive disease in 19 patients (44.2 %), in 3 patients the treatment was stopped due to toxicity (6.9 %). 12 patients received second-line treatment after early disease progression under first-line chemotherapy. 9 of these patients did not respond to second-line treatment, 2 achieved stable disease and 1 patient had partial remission. Elevated LDH and CA19.9 serum levels at the time of diagnosis were identified as negative prognostic factors. Conclusions: Prognosis of patients with advanced pancreatic cancer is still poor. Selected patients may benefit from salvage chemotherapy after failure of first-line chemotherapy. No significant financial relationships to disclose.

scholarly journals Is Immune Therapy Plus Chemotherapy More Effective Than Immune Therapy Alone for Unresectable Recurrent Nasopharyngeal Carcinoma?

2021 ◽  
Vol 12 ◽  
Author(s):  
Xin Zhou ◽  
XiaoShuang Niu ◽  
PeiYao Liu ◽  
Dan Ou ◽  
Yi Zhu ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Disease Progression ◽  
Immune Therapy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Combination Group ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy

ObjectiveTo evaluate whether the combination of immune checkpoint inhibitor (ICI) with chemotherapy is more effective than ICI alone in the treatment of recurrent, locoregionally advanced, unresectable nasopharyngeal carcinoma (RAU-NPC), which has progressed after second line chemotherapy.Methods and materialsPatients with RAU-NPC that progressed after second chemotherapy were prescribed ICI once every 3 weeks, either alone or combined with chemotherapy at the discretion of treating physicians, until confirmed disease progression, unacceptable toxicity, or voluntary withdrawal. The primary endpoint was the objective response rate (ORR). The secondary endpoints included safety, duration of response (DOR), and progression-free survival (PFS).ResultsFrom June 2016 to July 2021, 28 patients were enrolled in this study.21 patients received ICI plus chemotherapy, and 7 patients received ICI alone. Altogether, there were 7 (25%) complete response (CR) and 12 (42.8%) partial response (PR), respectively. Stable disease (SD) and progressive disease (PD) were defined in 4 (14.3%) and 5 (17.8%) cases, respectively. The ORR was 19 out of 28 (67.8%). The disease control rate (DCR) was 23 out of 28 (82.1%).Two patients (28.6%) in the ICI alone group and five (23.8%) in the combination group achieved CR (P=0.801). 2 patient (28.6%) in the ICI alone group and 10 (47.6%) in the combination group achieved PR (P=0.378). With a median follow-up of 16 months (2-61 months), five patients terminated ICI due to disease progression, one patient was lost to follow-up, and the remaining 22 patients continued with ICI. Neither the median PFS nor the median DOR was reached. All observed adverse events were defined as ≤ Grade 2.ConclusionICI alone or combined with chemotherapy demonstrated promising antitumor activity in RAU-NPC patients that progressed after second line chemotherapy, with a low toxicity profile. Compared with ICI alone, chemotherapy plus ICI did not improve CR or PR in our study.

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