An overview of SELECTTION: Survey of European lung cancer evaluating choice of treatment and tolerability in observed second-line non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18204-18204
Author(s):  
E. F. Smit ◽  
A. Vergnenegre ◽  
J. Arellano ◽  
K. Kraaij ◽  
A. Kral ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Treatment Options ◽  
Locally Advanced ◽  
Real Life ◽  
Primary Objective ◽  
Treatment Discontinuation ◽  
Line Treatment ◽  
Second Line ◽  
Significant Difference ◽  
Choice Of Treatment

18204 Background: In addition to established second-line treatments for NSCLC in Europe, docetaxel and pemetrexed; erlotinib, has recently been approved. The only study directly comparing alternative options in second-line NSCLC showed no significant difference in efficacy between docetaxel and pemetrexed (median survival 7.9 vs 8.3 months, p = 0.226) but significant differences in toxicity profile (Hanna et al, 2004). It is of interest to observe how different second-line treatment options are used in real life settings, particularly length of therapy, reasons for discontinuation and its impact on patient’s outcomes. Methods: In observational studies patients are not assigned to different treatments at random and physicians and patients decide on treatment. A careful design is paramount to ensure the correct interpretation of data obtained. SELECTTION is the first observational, non-interventional, prospective study to be carried out in Europe in second-line NSCLC treatment. The primary objective of SELECTTION is to assess the time from treatment initiation to treatment discontinuation. Secondary objectives are to observe the reasons for treatment discontinuation and assess its impact on patient’s outcomes. A total of 13 countries will participate including: France, Portugal, Germany, Denmark, and UK with approximately 200 sites enrolling 950 patients. Information regarding patients and disease characteristics and treatment history are collected. Patients may be enrolled if they have received first-line chemotherapy for locally advanced or metastatic NSCLC, and have subsequently progressed, are at least 18 years old and are about to initiate second line treatment. Treatment cohorts will be constructed based on the distribution of patients across second-line treatments by physician decision. Results: At this stage details about design and analyses planned as well as evolution of the study, will be presented. Conclusions: SELECTTION will provide a unique set of data on how patients with stage IIIb\/IV NSCLC previously treated with chemotherapy, are treated in routine clinical practice. No significant financial relationships to disclose.

Phase (Ph) 1b/2 evaluation of olaratumab in combination with gemcitabine and docetaxel in advanced soft tissue sarcoma (STS).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11517-11517
Author(s):  
Steven Attia ◽  
Victor Manuel Villalobos ◽  
Nadia Hindi ◽  
Brian Andrew Van Tine ◽  
Andrew J. Wagner ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Objective Response ◽  
Locally Advanced ◽  
Primary Objective ◽  
Clinical Activity ◽  
Parameter Estimates ◽  
Second Line ◽  
Line Therapy ◽  
Significant Difference ◽  
Ecog Ps

11517 Background: Doxorubicin (doxo) remains standard first-line therapy for advanced STS. Doxo in combination with olaratumab (O) demonstrated superior clinical activity compared to doxo alone in a Ph 2 trial (NCT01185964), although this was not confirmed in the subsequent Ph 3 trial (NCT02451943). Gemcitabine (G) plus docetaxel (D) is a second line therapy for advanced STS. Here, we report a concurrent Ph 2 study that explored a second-line addition of O to G and D for advanced STS (ANNOUNCE 2 NCT02659020). Methods: Adult patients (pts) with unresectable locally advanced or metastatic STS, ≤ 2 prior lines of systemic therapy, and ECOG PS 0-1 were eligible. Pts were enrolled from 2 cohorts: O-naïve and O-pretreated. In both cohorts, pts were randomized 1:1 to either O, G plus D or placebo (PBO), G plus D. Pts received 21-day cycles of O (20 mg/ kg cycle 1 and 15 mg/kg other cycles, day (d) 1 and d8), G (900 mg/m2, d1 and d8) and D (75 mg/m2, d8). Pts continued treatment until progression, toxicity, or withdrawal. Randomization was stratified by histology (leiomyosarcoma [LMS] vs non-LMS), prior systemic therapy, ECOG PS, and prior pelvic radiation. The primary objective was overall survival (OS) in the O-naïve population using an alpha level of 0.20. Secondary endpoints included OS (O-pretreated) and other efficacy parameters, as well as safety and pharmacokinetics (PK). Results: 167 pts were enrolled in the O-naïve cohort and 89 pts in the O-pretreated cohort. Baseline patient characteristics were well balanced. OS for O-naïve pts was 16.8 vs 18.0 months (m) (hazard ratio [HR] = 0.95, 95% CI: 0.64-1.40; p = 0.78) for the investigational vs control arm, respectively. Other efficacy outcomes are presented in the table. Safety was manageable across treatment arms. PK parameter estimates for O were consistent with previous studies. Conclusions: There was no statistically significant difference in OS between the two arms in the O-naïve population. However, while not statistically significant, the combination of O, G and D demonstrated favorable OS in the O-pretreated cohort, and PFS and objective response rate (ORR) in both cohorts. For O-naïve pts, a clinically meaningful progression-free survival (PFS) improvement was observed. Further investigations in specific histological subtypes are ongoing. Clinical trial information: NCT02659020. [Table: see text]

Saving the best to the last: Can we wait for second-line?

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7013-7013
Author(s):  
Renana Barak ◽  
Ido Wolf
Keyword(s):  
Bile Duct ◽  
Treatment Options ◽  
Locally Advanced ◽  
Real Life ◽  
Good Treatment ◽  
Line Treatment ◽  
Line Therapy ◽  
Real Life Data ◽  
Disease Site ◽  
Tumor Types

7013 Background: A common perception of some oncologists is that the vast majority of their patients with metastatic disease will receive 2nd line treatment upon progression. Therefore, “saving” good treatment options for the future may be acceptable. We aimed to examine whether this perception correlates with real-life. Methods: Using an oncology electronic database, consisting of >27,000 patients treated at our institution, we selected consecutive patients with metastatic or locally advanced lung, colon, pancreatic, bile duct and gastric cancers who started standard 1st line, consisting of at least doublet therapy. We then assessed the correlation between proceeding to 2nd line therapy and demographic and clinical variables, including age, gender, initial BMI, hemoglobin, WBC, creatinine, glucose, calcium, as well as survival. Results: A total of 553 patients met the inclusion criteria. Their median age was 66 and 317 were men. Their diagnoses were colon (197), lung (129), pancreas (101), bile duct (71) and gastric (55) cancers. Only 59% received at least one course of 2nd line treatment (61.9% colon, 65.1% lung, 66.3% pancreas, 35.2% bile duct and 54.5% gastric). Probability of reaching 2nd line treatment was associated with disease site (P=0.0002) as well as with age, with patients who received 2nd line being 2.5 years younger compared to those who did not (65 vs. 67.5 years, P=0.008). No other factor, including gender, BMI or standard laboratory values at presentation could predict chances of proceeding to 2nd line, for either the whole group or by primary cancer origin. Survival of patients not starting 2nd line was also significantly shorter across all tumor types. Conclusions: These real-life data indicate that only 60% of patients starting standard doublet or triplet treatment for advanced cancers will commence 2nd line therapy; and this cannot be reliably predicted in advance using standard clinical and laboratory characteristics. Our data challenge the practice of saving good treatment options for subsequent lines, and call for the development of tools enabling prediction of response and tolerance to treatment, pursuing for better patient selection and patient-tailored therapy.

Saving the best to the last: Can we wait for second-line?

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 284-284
Author(s):  
Renana Barak ◽  
Barliz Waissengrin ◽  
Ido Wolf
Keyword(s):  
Bile Duct ◽  
Performance Status ◽  
Treatment Options ◽  
Real Life ◽  
Good Treatment ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
Line Therapy

284 Background: A common perception of some oncologists is that the vast majority of their patients with metastatic disease will receive second-line treatment upon progression. Therefore, “saving” good treatment options for the future may be acceptable. We aimed to examine whether this perception correlates with real-life. Methods: Using an oncology electronic database, consisting of >27,000 patients treated at our institution, we selected consecutive patients with metastatic or locally advanced lung, colon, pancreatic, bile duct and gastric cancers who started standard first-line. We then assessed the correlation between proceeding to second-line therapy and demographic and clinical variables, including age, gender, initial performance status, BMI, hemoglobin, WBC, creatinine, glucose, calcium, as well as duration on first line therapy and survival. Results: A total of 492 patients met the inclusion criteria. Their median age was 67 and 285 were men. Their diagnoses were colon (169), lung (102), pancreas (101), bile duct (65) and gastric (55) cancers. Only 52% (255) received second-line treatment for at least 30 days (36% colon, 26% lung, 18% pancreas, 9% bile duct and 11% gastric). Receipt of second-line therapy was associated with disease site (P=0.001) as well as with age, with patients who received second-line being 5 years younger compared to those who did not (64 vs. 69 years, P=0.004). Patients who reached second-line had better performance status and higher hemoglobin level at presentation, additionally their median duration on first-line chemotherapy was substantially longer (P<0.007 for all comparisons). Survival of patients not starting second-line was significantly shorter across all tumor types (19.8 vs 6.5 months P=0.001). General deterioration and toxicity were the major reasons for avoiding second-line therapy at progression, 43% and 30% respectively. Conclusions: These real-life data indicate that only half of the patients starting standard doublet or triplet treatment for advanced cancers will commence second-line therapy; and this can be hardly predicted in advance using standard clinical and laboratory characteristics. Our data challenge the practice of saving good treatment options for subsequent lines, and call for the development of tools enabling prediction of response and tolerance to treatment, pursuing for better patient selection and patient-tailored therapy.

A randomised phase II study of pemetrexed versus pemetrexed+erlotinib as second-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer

2014 ◽  
Vol 50 (9) ◽  
pp. 1571-1580 ◽  
Author(s):  
Christian Dittrich ◽  
Zsolt Papai-Szekely ◽  
Nuria Vinolas ◽  
Christer Sederholm ◽  
Joerg T. Hartmann ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung

Cabazitaxel (Cbz) versus topotecan in patients (pts) with small cell lung cancer (SCLC) that has progressed during or after first-line treatment with platinum-based chemotherapy: A randomized phase II study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS7609-TPS7609
Author(s):  
Tracey L. Evans ◽  
Joo-Hang Kim ◽  
Frances A. Shepherd ◽  
Konstantinos N. Syrigos ◽  
Katalin Udud ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Disease Progression ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Unmet Need ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Platinum Based Chemotherapy

TPS7609 Background: Approximately 12–15% of pts with lung cancer have SCLC. Although first-line platinum-based chemotherapy regimens may be effective, pts often experience rapid relapse and develop systemic metastases. Median survival after SCLC relapse varies from 13 to 35 weeks. As such, there is a substantial unmet need for more effective second-line treatments. Clinical studies suggest that taxanes are effective in relapsed SCLC, and Cbz, a next-generation taxane, has shown efficacy in the second-line treatment of taxane-resistant tumors (de Bono JS, et al. Lancet 2010;376: 1147–54; Pivot X, et al. Ann Oncol 2008;19:1547–52). Assessment of Cbz treatment for SCLC is therefore warranted. Methods: This is a multinational, open-label Phase II study (NCT01500720) in pts with confirmed, measurable, locally advanced or metastatic SCLC whose disease has progressed during/after first-line platinum-based chemotherapy. Pts aged ≥ 18 years with ECOG performance status ≤ 1 are eligible, but those with > 1 prior chemotherapy regimen or prior topotecan or taxane use are excluded. Pts are randomized 1:1 to receive IV Cbz 25 mg/m2 (Day 1 Q3W) or IV topotecan 1.5 mg/m2 (Days 1–5 Q3W). Pts are divided into chemo-sensitive and chemo-refractory subgroups, while stratification is based on the presence of brain metastases (yes vs no) and by lactate dehydrogenase plasma concentration (≤ or > upper limit). Pts will be treated until disease progression, unacceptable toxicity or withdrawal of consent. The primary objective is assessment of progression-free survival (PFS). Secondary objectives include assessment of other efficacy endpoints (proportion of pts free of disease progression at 12 weeks, tumor response and overall survival), safety and health-related quality of life. A centralized imaging review process is being used to independently review tumor measurements. Planned enrollment is 172 pts (to provide 80% power for PFS analysis). The first pt was enrolled in March 2012. By December 2012, 91 pts had been randomized in 38 sites. Clinical trial information: NCT01500720.

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