Stereotactic body radiotherapy and systemic dose chemotherapy for locally advanced lung cancer, single-arm phase II study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21081-e21081
Author(s):  
Greg Kubicek ◽  
Polina Khrizman ◽  
Christian Michael Squillante ◽  
Qianyi Xu ◽  
Wissam Abouzgheib ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Overall Survival ◽  
Failure Rate ◽  
Locally Advanced ◽  
Lung Tumors ◽  
Full Dose ◽  
Grade 3 ◽  
One Year

e21081 Background: The outcomes for locally advanced non-small cell lung cancer (NSCLC) are overall poor. This is a single arm phase 2 study (Clinical trials.gov NCT02568033) evaluating the role of stereotactic body radiosurgery (SBRT) along with full dose systemic chemotherapy in the treatment of unresectable stage 2 and stage 3 NSCLC. Methods: patients were treated with SBRT to all sites of gross disease. Dosing consisted of 60 Gy in 3 fractions for peripheral lung tumors, 50 Gy in 5 fractions for central lung tumors, and 40-50 Gy in 5 fractions for hilar and mediastinal lymph nodes. Chemotherapy was histology dependent and consisted of 4 cycles, there was a 7 days break between chemotherapy and SBRT. Quality of life was measured using FACT-L. Results: Twenty two patients were enrolled and analyzed. 17 (77 %) were stage III and 19 (86%) had lymph node involvement. Median follow-up for all patients was 23.1 months. Median overall survival is 27.2 months. Overall survival at one year was 82% and overall survival at two years was 53%. Two year regional failure rate 19%. Two year distant failure rate 47.2%. Quality of life scores at one year were available for 12 patients and were unchanged compared to baseline. Acute toxicity grade 3 or greater was seen in 6 patients and late toxicity grade 3 or higher was seen in 2 patients. Conclusions: A combination of SBRT and full dose chemotherapy appears to be a safe and effective treatment for locally advanced NSCLC and warrants further investigation. Clinical trial information: NCT02568033 .

Randomized phase III trial of S-1 plus cisplatin versus docetaxel plus cisplatin for advanced non-small-cell lung cancer (TCOG0701).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7515-7515 ◽  
Author(s):  
Nobuyuki Katakami ◽  
Akihiko Gemma ◽  
Hiroshi Sakai ◽  
Kaoru Kubota ◽  
Makoto Nishio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

7515 Background: Although molecularly targeted therapy improves outcome of selected patients with advanced non-small-cell lung cancer (NSCLC), most of the patients ultimately become candidates of cytotoxic chemotherapy, which is the cornerstone of patient management. S-1 plus cisplatin (SP) has shown activity and good tolerability in phase II settings. Docetaxel plus cisplatin (DP) is the only third-generation regimen that demonstrated statistically significant improvement of overall survival and quality of life by head to head comparison with a second-generation regimen, vindesine plus cisplatin, in patients with advanced NSCLC. Methods: Patients with previously untreated stage IIIB or IV NSCLC, an ECOG PS of 0-1 and adequate organ functions were randomized to receive either oral S-1 80 mg/m2/day (40 mg/m2 b.i.d.) on days 1 to 21 plus cisplatin 60 mg/m2 on day 8 every 5 weeks or docetaxel 60mg/m2 on day 1 plus cisplatin 80 mg/m2 on day 1 every 3 weeks, both up to 6 cycles. The primary endpoint is overall survival (OS). Non-inferiority study design was employed as upper confidence interval (CI) limit for HR<1.322. Secondary endpoints include progression-free survival (PFS), response, safety, and quality of life (QOL). Results: From April 2007 to December 2008, 608 patients from 66 sites in Japan were randomized to SP (n=303) or DP (n=305). Patient demographics were well balanced between the two groups. Two interim analyses were preplanned. At the final analysis, total of 480 death events were observed. The primary endpoint was met. OS for SP was non inferior to DP (median survival, 16.1 v 17.1 months, respectively; HR=1.013; 96.4% CI, 0.837-1.227). PFS was 4.9 months in the SP arm and 5.2 months in the DP arm. Statistically significantly lower rate of febrile neutropenia (7.4% v 1.0%), grade 3/4 neutropenia (73.4% v 22.9%), grade 3/4 infection (14.5% v 5.3%), grade 1/2 alopecia (59.3% v 12.3%) were observed in the SP arm than in the DP arm. QOL data investigated by EORTC QLQ-C30 and LC-13 favored for the SP arm. Conclusions: S-1 plus cisplatin is a standard first-line chemotherapy regimen for advanced NSCLC.

Phase III Trial of Gemcitabine Plus Carboplatin Versus Single-Agent Gemcitabine in the Treatment of Locally Advanced or Metastatic Non–Small-Cell Lung Cancer: The Swedish Lung Cancer Study Group

2005 ◽  
Vol 23 (33) ◽  
pp. 8380-8388 ◽  
Author(s):  
Christer Sederholm ◽  
Gunnar Hillerdal ◽  
Kristina Lamberg ◽  
Karl Kölbeck ◽  
Monika Dufmats ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Overall Survival ◽  
Single Agent ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase Iii ◽  
Time To Progression ◽  
Small Cell Lung

PurposeThis phase III study compared overall survival in patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) when treated with single-agent gemcitabine versus gemcitabine/carboplatin. Secondary objectives were to compare response, time to progression, toxicity, and quality of life.Patients and MethodsChemotherapy-naive patients received either gemcitabine alone (1,250 mg/m2on days 1 and 8; gemcitabine arm) or with carboplatin (area under the curve 5 on day 1; GC arm) every 21 days.ResultsDemographics and disease characteristics of 334 randomly assigned patients were comparable on both arms. An intent-to-treat analysis showed significantly better overall survival (log-rank P = .0205) and 2-year survival (15% v 5%; P = .009) favoring the GC arm. Per Cox multivariate analysis, only two covariates, treatment arm (GC v G) and baseline performance status (0 or 1 v 2), independently influenced survival. Per-protocol analyses showed significantly longer median time to progression (5.7 v 3.9 months; P = .0001) and significantly higher objective response rate (29.6 v 11.3%; P < .0001) in the GC arm. Grade 3 to 4 leucopenia and thrombocytopenia were significantly more pronounced in the GC arm (P for both variables < .001) but importantly without associated increases in fever, infection, bleeding, or hospitalizations. There was no discernible difference in global quality-of-life patterns between treatment arms.ConclusionIn advanced NSCLC, gemcitabine/carboplatin therapy resulted in significant survival benefit compared with single-agent gemcitabine without undue increase in toxicity.

Outcomes of Proton Therapy for Non-small Cell Lung Cancer in Patients with Interstitial Pneumonia

2021 ◽  
Author(s):  
Shingo Hashimoto ◽  
Hiromitsu Iwata ◽  
Yukiko Hattori ◽  
Koichiro Nakajima ◽  
Kento Nomura ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Cancer Treatment ◽  
Small Cell Lung Cancer ◽  
Interstitial Pneumonia ◽  
Proton Therapy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

Abstract Background:Interstitial pneumonia (IP) is a disease with a poor prognosis. In addition, IP patients are more likely to develop lung cancer. Since IP patients frequently develop toxicities during cancer treatment, minimally invasive cancer treatment is warranted for such patients to maintain their quality of life. This study retrospectively investigated the efficacy and safety of proton therapy (PT) for non-small cell lung cancer (NSCLC) in patients with IP.Methods:Twenty-nine NSCLC patients with IP were treated with PT between September 2013 and December 2019. The patients had stage IA to IIIB primary NSCLC. Ten of the 29 patients exhibited the usual interstitial pneumonia pattern. The prescribed dose was 66-74 Grays (relative biological effectiveness) in 10-37 fractions.Results:The median follow-up period was 17.4 months (interquartile range (IQR), 9.5–32.7). The median patient age was 77 years (IQR, 71–81). The median planning target volume was 112.0 ml (IQR, 56.1–246.3). The 2-year local control, progression-free survival, and overall survival rates were 77% (95% confidence interval: 34 to 94), 31% (13–50), and 50% (26–70), respectively. According to the Common Terminology Criteria for Adverse Events (version 4.0), grade 3 acute radiation pneumonitis (RP) was observed in 1 patient. Two patients developed grade 3 late RP, but no other patients experienced serious toxicities. The patients’ quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-LC13 and SF-36) scores had not changed after 3 months.Conclusions:PT may safely control NSCLC without adversely affecting the daily lives of IP patients.

scholarly journals Pretreatment Quality of Life Is an Independent Prognostic Factor for Overall Survival in Patients with Advanced Stage Non-small Cell Lung Cancer

2009 ◽  
Vol 4 (9) ◽  
pp. 1075-1082 ◽  
Author(s):  
Yingwei Qi ◽  
Steven E. Schild ◽  
Sumithra J. Mandrekar ◽  
Angelina D. Tan ◽  
James E. Krook ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Overall Survival ◽  
Prognostic Factor ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Advanced Stage ◽  
Small Cell Lung

Phase III Trial Comparing Supportive Care Alone With Supportive Care With Oral Topotecan in Patients With Relapsed Small-Cell Lung Cancer

2006 ◽  
Vol 24 (34) ◽  
pp. 5441-5447 ◽  
Author(s):  
Mary E.R. O'Brien ◽  
Tudor-Eliade Ciuleanu ◽  
Hristo Tsekov ◽  
Yaroslav Shparyk ◽  
Branka Čučeviá ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Supportive Care ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3 ◽  
Oral Topotecan

Purpose For patients with small-cell lung cancer (SCLC), further chemotherapy is routinely considered at relapse after first-line therapy. However, proof of clinical benefit has not been documented. Patients and Methods This study randomly assigned patients with relapsed SCLC not considered as candidates for standard intravenous therapy to best supportive care (BSC) alone (n = 70) or oral topotecan (2.3 mg/m2/d, days 1 through 5, every 21 days) plus BSC (topotecan; n = 71). Results In the intent-to-treat population, survival (primary end point) was prolonged in the topotecan group (log-rank P = .0104). Median survival with BSC was 13.9 weeks (95% CI, 11.1 to 18.6) and with topotecan, 25.9 weeks (95% CI, 18.3 to 31.6). Statistical significance for survival was maintained in a subgroup of patients with a short treatment-free interval (≤ 60 days). Response to topotecan was 7% partial and 44% stable disease. Patients on topotecan had slower quality of life deterioration and greater symptom control. Principal toxicities with topotecan were hematological: grade 4 neutropenia, 33%; grade 4 thrombocytopenia, 7%; and grade 3/4 anemia, 25%. Comparing topotecan with BSC, infection ≥ grade 2 was 14% versus 12% and sepsis 4% versus 1%; other grade 3/4 events included vomiting 3% versus 0, diarrhea 6% versus 0, dyspnea 3% versus 9%, and pain 3% versus 6%. Toxic deaths occurred in four patients (6%) in the topotecan arm. All cause mortality within 30 days of random assignment was 13% on BSC and 7% on topotecan. Conclusion Chemotherapy with oral topotecan is associated with prolongation of survival and quality of life benefit in patients with relapsed SCLC.

Residual deficits in quality of life one year after intensity-modulated radiotherapy for patients with locally advanced head and neck cancer

2015 ◽  
Vol 191 (6) ◽  
pp. 501-510 ◽  
Author(s):  
Silke Tribius ◽  
Marieclaire Raguse ◽  
Christian Voigt ◽  
Adrian Münscher ◽  
Alexander Gröbe ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Locally Advanced ◽  
Intensity Modulated Radiotherapy ◽  
Advanced Head ◽  
Intensity Modulated ◽  
One Year

A phase Ib/IIa study of combination therapy with gemcitabine and Atu027 in patients with locally advanced or metastatic pancreatic adenocarcinoma.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 385-385 ◽  
Author(s):  
Beate Schultheis ◽  
Dirk Strumberg ◽  
Jan Kuhlmann ◽  
Martin Wolf ◽  
Karin Link ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Combination Therapy ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Small Patient Number ◽  
The Difference ◽  
Grade 3

385 Background: Atu027 is a liposomally formulated short interfering RNA with anti-metastatic activity, which silences expression of protein kinase N3 (PKN3) in the vascular endothelium. PKN3 acts as a Rho effector downstream of PI3K. This trial was designed to assess safety, pharmacokinetics and efficacy of Atu027 in combination with gemcitabine in advanced pancreatic carcinoma (APC). Methods: 23 patients (pts) with APC stage 3 or 4 were enrolled and randomly assigned to different Atu027 dosing schedules (arm 1: 0.253mg/kg once weekly, n = 11; arm 2: 0.253mg/kg twice-weekly, n = 12) but identical gemcitabine regimen. Response was evaluated according to RECIST 1.1. Quality of life was assessed with EORTC questionnaire QLQ-C30. Results: Combination therapy with Atu027 and gemcitabine was given up to 7.8 months until progression. Grade 3 adverse events (AEs) were reported by 9/11 pts (82%) in arm 1 and 11/12 pts (92%) in arm 2. Grade 4 AEs were reported by two pts in each arm. Interestingly, there was a difference in median progression free survival (mPFS) between the two treatment arms. Arm 1 showed an mPFS of 1.8 [95%CI: 0.4-5.5] months vs. 5.3 [95%CI: 1.5-6.0] months in arm 2, p= 0.399. In a post-hoc analysis of metastatic disease only, the difference in mPFS between the two arms reached statistical significance (1.6 [95%CI:0.4-2.1] vs 2.9 [95%CI:1.0-7.3] months, n = 9 vs 10, p= 0.025). Disease control during treatment was achieved in 4/11 (36%) pts in arm 1 and in 7/12 (58%) pts in arm 2. New lesions occurred in all (6/6) pts in arm 1 who had at least one RECIST re-evaluation but only 5/10 pts (50%) in arm 2. In quality of life analysis, pts in the once-weekly arm showed a stable global health status while pts in the twice-weekly arm reported an improvement (0-100 score change from baseline: -2.3 vs +21.6 after one cycle, N = 7 vs 7). Conclusions: Combination of Atu027 with gemcitabine for the treatment of APC is safe and was well tolerated. Despite the small patient number, there is a clear signal that twice-weekly Atu027 dosing might be superior to the once-weekly regimen. These results suggest efficacy of Atu027 and warrant further investigation with Atu027 added to standard of care in APC. Clinical trial information: NCT01808638.

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