scholarly journals Real-world prospective analysis of treatment patterns in durvalumab maintenance after chemoradiotherapy in unresectable, locally advanced NSCLC patients

2021 ◽  
Author(s):  
Julian Taugner ◽  
Lukas Käsmann ◽  
Chukwuka Eze ◽  
Alexander Rühle ◽  
Amanda Tufman ◽  
...  
Keyword(s):  
Prospective Study ◽  
Real World ◽  
Maintenance Treatment ◽  
Progressive Disease ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Contrast Enhanced Ct ◽  
Unresectable Stage ◽  
Locally Advanced Nsclc

SummaryThe aim of this prospective study is to evaluate the clinical use and real-world efficacy of durvalumab maintenance treatment after chemoradiotherapy (CRT) in unresectable stage, locally advanced non-small cell lung cancer (NSCLC). All consecutive patients with unresectable, locally advanced NSCLC and PD-L1 expression (≥1%) treated after October 2018 were included. Regular follow up, including physical examination, PET/CT and/or contrast-enhanced CT-Thorax/Abdomen were performed every three months after CRT. Descriptive treatment pattern analyses, including reasons of discontinuation and salvage treatment, were undertaken. Statistics were calculated from the last day of thoracic irradiation (TRT). Twenty-six patients were included. Median follow up achieved 20.6 months (range: 1.9–30.6). Durvalumab was initiated after a median of 25 (range: 13–103) days after completion of CRT. In median 14 (range: 2–24) cycles of durvalumab were applied within 6.4 (range 1–12.7) months. Six patients (23%) are still in treatment and seven (27%) have completed treatment with 24 cycles. Maintenance treatment was discontinued in 13 (50%) patients: 4 (15%) patients developed grade 3 pneumonitis according to CTCAE v5 after a median of 3.9 (range: 0.5–11.6) months and 7 (range: 2–17) cycles of durvalumab. Four (15%) patients developed grade 2 skin toxicity. One (4%) patient has discontinued treatment due to incompliance. Six and 12- month progression-free survival (PFS) rates were 82% and 62%, median PFS was not reached. No case of hyperprogression was documented. Eight (31%) patients have relapsed during maintenance treatment after a median of 4.8 (range: 2.2–11.3) months and 11 (range: 6–17) durvalumab cycles. Two patients (9%) developed a local-regional recurrence after 14 and 17 cycles of durvalumab. Extracranial distant metastases and brain metastases as first site of failure were detected in 4 (15%) and 2 (8%) patients, respectively. Three (13%) patients presented with symptomatic relapse. Our prospective study confirmed a favourable safety profile of durvalumab maintenance treatment after completion of CRT in unresectable stage, locally advanced NSCLC in a real-world setting. In a median follow-up time of 20.6 months, durvalumab was discontinued in 27% of all patients due to progressive disease. All patients with progressive disease were eligible for second-line treatment.

Infusional topotecan with concurrent radiation followed by consolidation etoposide platinum and docetaxel for patients with high risk unresectable stage III non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17042-17042
Author(s):  
S. Seung ◽  
B. K. Fisher ◽  
H. J. Ross
Keyword(s):  
High Risk ◽  
Continuous Infusion ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Stage Iii ◽  
Consolidation Chemotherapy ◽  
Cns Metastases ◽  
Unresectable Stage ◽  
Locally Advanced Nsclc ◽  
Grade 3

17042 Background: Good PS patients (pts) with locally advanced NSCLC treated with concurrent chemoradiotherapy have a 20–40% 3 year survival. Treatment is arduous and poor PS or high risk pts often cannot complete a full course of treatment. The optimal combination of chemotherapy and radiation and the role of consolidation chemotherapy are unknown. Despite response rates exceeding 50%, most pts eventually progress with brain as the first site of relapse in up to 30%. Continuous infusion chemotherapy is better tolerated than intermittent chemotherapy combined with radiation and may improve outcome in other locally advanced aerodigestive malignancies, however it has not been studied extensively in NSCLC. Topotecan is active in NSCLC, can safely be combined with radiation, can be given by continuous infusion and penetrates the CNS making it an attractive study agent in locally advanced NSCLC. Methods: In this pilot study, 20 pts were treated with infusional topotecan 0.4 mg/m2/d with 3D conformal radiation to 63 Gy both delivered M-F for 7 weeks. Pts without progressive disease underwent consolidation chemotherapy with etoposide and platinum for one cycle to take advantage of upregulation of topoisomerase II by topotecan. Two cycles of docetaxel consolidation followed. Study endpoints include response, time to progression, survival, toxicity and development of CNS metastases. Results: All pts have completed induction chemoradiotherapy. 12/20 have completed consolidation. 17/20 pts had a PR and 1/20 SD after induction chemoradiation. 1 pt developed CNS metastases 228 days after study entry and is alive with disease at 541 days. 3 pts had pulmonary emboli. Therapy has been well tolerated with 1/20 grade 4 lymphopenia. Grade 3 hematologic toxicity was seen in 17/20 pts. Other grade 3 toxicities include esophagitis (3/20), esophageal stricture (2/20), pneumonitis (6/20), fatigue (6/20), weight loss (1/20). Conclusion: Continuous infusion topotecan with radiation is well tolerated and shows evidence of activity in the management of poor risk patients with unresectable stage III NSCLC. Survival data will be presented at the meeting. No significant financial relationships to disclose.

scholarly journals P2.02-016 Real World Experience with Chemoradiotherapy in Locally Advanced NSCLC

2017 ◽  
Vol 12 (1) ◽  
pp. S856
Author(s):  
Joaquín Gimeno ◽  
Irene Torres ◽  
Jorge Hernando ◽  
Ana Comin ◽  
Isabel Pajares ◽  
...  
Keyword(s):  
Real World ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Locally Advanced Nsclc

Randomized trial of thoracic radiotherapy with or without concurrent daily low-dose carboplatin in elderly patients with locally advanced non-small cell lung cancer (NSCLC): Long-term follow-up of Japan Clinical Oncology Group (JCOG) Study JCOG0301.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8532-8532 ◽  
Author(s):  
Shinji Atagi ◽  
Junki Mizusawa ◽  
Satoshi Ishikura ◽  
Toshiaki Takahashi ◽  
Hiroaki Okamoto ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Initial Report ◽  
Locally Advanced Nsclc ◽  
Long Term Follow Up ◽  
Grade 3

8532 Background: In the phase III JCOG0301 trial, concurrent chemoradiotherapy (CRT) was compared with radiotherapy (RT), demonstrating clinically significant survival benefits in elderly patients with locally advanced NSCLC after a median follow-up of 19.4 months. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT are poorly understood for elderly patients. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years. Methods: Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT alone (RT arm: irradiation with 60 Gy in 30 fractions) or CRT (CRT arm: the same RT with additional concurrent use of carboplatin 30 mg/m2 per fraction up to the first 20 fractions). The primary endpoint was overall survival (OS). Prognosis and adverse events data were collected beyond those in the initial report of this trial. Kaplan-Meier survival curves and 3- and 5-year survival proportions were calculated. Late toxicities were defined as occurring later than 90 days after RT initiation. Results: From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better OS than the RT arm (HR = 0.743, 95% CI = 0.552 – 0.998, one-sided p = 0.0239 by stratified log-rank test). In the RT and CRT arms, median OS was 16.5 and 21.7 months, 3-year survival was 16.3% and 34.3%, and 5-year survival was 9.2% and 15.2%, respectively. %Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) were seen since the initial report. There were 7 treatment-related deaths, all of which were recorded in the initial report: 4 (4.0%) in the RT arm and 3 (3.0%) in the CRT arm. Conclusions: Long-term follow-up confirms the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT, as compared with RT alone. Clinical trial information: 00132665.

Post-PACIFIC trial era: Patterns of outcomes and toxicities from a single private institution in a developing country.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21005-e21005
Author(s):  
Daniel Przybysz
Keyword(s):  
Advanced Nsclc ◽  
Locally Advanced ◽  
Current Data ◽  
Inclusion Criteria ◽  
Private Institution ◽  
Histologic Subtype ◽  
Locally Advanced Nsclc ◽  
Study Results ◽  
Cutaneous Rash

e21005 Background: Despite the twenty-first century, NSCLC remains the leading cause of cancer related deaths in a great variety of nations around the globe. However, the scenario has changed dramatically in the past 5 years. Immunotherapy features have opened a gigantic range of combinations now possible towards a better suited treatment for these patients. And we have seen results as we have never before - even in developing countries. Therefore, the goal of this study was to retrospectively analyze the patterns of outcomes, toxicities and safeness in the post-PACIFIC trial era, reporting results on patients that underwent chemoradiation followed by immunotherapy. Methods: We retrospectively collected and analyzed data on patients diagnosed with locally-advanced NSCLC treated in a single private institution in Rio de Janeiro, Brazil, between January 2017 and May 2019. All electronic medical records were accessed in order to obtain demographics, treatment and follow-up pattern data. Patients that received full chemoradiation treatment were included. Patients that did not meet the inclusion criteria were excluded from the study. Results: 121 patients were analyzed. 38 did not meet the inclusion criteria, and were excluded. The median age was 73.5y (50-95). 55% (46) were females. 59% (49) patients were smokers, 12% non-smokers. 29% of them did not have that info on their EMR. Adenocarcinoma was the most common histologic subtype (67%). All patients received chemotherapy regimen according to the best suited to patient, being carbo-taxol the most commonly used one (73%). All patients received radiation therapy, and the mostly used scheme was 60Gy in 30 fractions (38.5%). During a medium follow-up of 1.2 years on Durvalumab, 8 patients died (9.6%), none of them being a treatment-related death. Most toxicities presented during treatment and follow-up were mucositis (62.5%), cough (52%), cutaneous rash (48.8%). Other minor toxicities were nauseas (22.9%) and hematologic (14.5%). No grade 5 toxicity was reported. Conclusions: This study carries limitations inherent to retrospective analysis. Yet, we found the utmost importance on understanding how our patient population is responding to this new era of NSCLC-oncology. Despite all issues related within a developing nation, we showed that our results are compatible with the current data published. The treatment of locally advanced NSCLC brings exciting results and a big hope for these patients.

Sign in / Sign up

Export Citation Format

Share Document