All times are listed in CET (Central European Time)
- J. Van Loon (Maastricht, Netherlands)
- J. Edwards (Sheffield, United Kingdom)
78MO - Early safety assessment of durvalumab after sCRT in patients with Stage III, unresectable NSCLC (PACIFIC-6)
- M. Garassino (Chicago, IL, United States of America)
- M. Garassino (Chicago, IL, United States of America)
- J. Mazieres (Toulouse, France)
- M. Reck (Grosshansdorf, Germany)
- A. Delmonte (Meldola, Italy)
- H. Bischoff (Heidelberg, Germany)
- R. Bernabe (Seville, Spain)
- I. Díaz Pérez (Gaithersburg, MD, United States of America)
- W. Sawyer (Cambridge, United Kingdom)
- N. Trunova (Gaithersburg, MD, United States of America)
- C. Faivre-Finn (Manchester, United Kingdom)
Abstract
Background
In the ph III PACIFIC trial, durvalumab after concurrent chemoradiotherapy (cCRT) significantly improved survival outcomes in pts with Stage III, unresectable NSCLC with manageable safety. As many pts are ineligible for cCRT, we aimed to assess durvalumab after sequential (s)CRT in pts with Stage III, unresectable NSCLC in the ph II PACIFIC-6 trial (NCT03693300).
Methods
Up to 120 pts with ECOG PS ≤2 and no progression after sCRT will receive durvalumab 1500 mg IV q4w ≤24 months or until progression, unacceptable toxicity or consent withdrawal. The primary endpoint is assessment of safety/tolerability, defined by gr 3/4 treatment-related AEs occurring within 6 months. Pre-specified early assessment was planned after ≥50 pts in a PS 0/1 cohort (∼100–120 expected) had received durvalumab ≥6 months.
Results
As of August 24, 2020, 50 pts with ECOG PS 0/1 (46%/54%) had received durvalumab for a median 24.0 weeks. Median age was 67.0 years; 64% were male; 64% had adenocarcinoma histology; 38%/52%/10% had Stage IIIA/B/C disease; and 48%/52% had PD-L1 tumor cell expression ≥/< 1%. Many pts had past/present medical conditions, including vascular (62%), metabolism (54%) and respiratory (50%) disorders. Pts had received a median 4 CT cycles, with 68% receiving a total RT dose of ≥54 to ≤60 Gy and 32% receiving >60 to ≤66 Gy. In most pts (84%), CT and RT did not overlap. Best response to prior sCRT (RECIST 1.1) included PR (74%) and SD (18%). In all, 88% had any AEs and 12% had gr 3/4 AEs; 70% had any possibly related AEs (PRAEs) and 4% had gr 3/4 PRAEs (including 2% with the gr 3/4 PRAE pneumonitis). 22% had SAEs (10% PRSAEs) and 2 pts had fatal AEs (1 pt fatal PRAE). 72% had AESIs, including pneumonitis (32%) and dermatitis/rash (28%). 9/25 pts who discontinued did so due to AEs, most commonly pneumonitis (n = 8).
Conclusions
Based on early assessment, durvalumab after sCRT appears to have a similar safety profile to that with durvalumab after cCRT in PACIFIC pts with Stage III, unresectable NSCLC. Full cohort results for safety primary analysis in the near future are awaited.
Clinical trial identification
NCT03693300.
Editorial acknowledgement
Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Andrew Gannon of Cirrus Communications (New York, NY), an Ashfield company, and was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
M.C. Garassino: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, MISP in Thimic malignancies; Speaker, advisory board: Eli Lilly; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Local PI, Enrollment in clinical Trials in NSCLC; Speaker;advisory board: Otsuka Pharma; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment and Steering Committee in clinical Trials in NSCLC; Consulting, advisory boards, lectures; steering committee: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; advisory board: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: Roche; Advisory/Consultancy, Research grant/Funding (self), PI, MISP MISP Sunitinib in thymic malignancies; advisory board: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Incyte; Advisory/Consultancy: Inivata; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Research grant/Funding (self), PI, Enrollment in clinical Trials Thimic malignancies: Tiziana Sciences; Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Clovis; Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Merck Serono; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials in Mesothelioma; advisory board: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; consulting, advisory boards, lectures; steering committee: MSD; Advisory/Consultancy, Research grant/Funding (self), Local PI, Enrollment and Steering committee in clinical Trials in NSCLC; advisory board: GlaxoSmithKline S.p.A.; Advisory/Consultancy, Research grant/Funding (self), Advisory board; PI, Enrollment in clinical Trials: Sanofi-Aventis; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials; Advisory board; steering committee: Spectrum Pharmaceutcials; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials; Advisory board; steering committee: Blueprint Medicine; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Daiichi Sankyo; Research grant/Funding (institution): Merck KGaA; Advisory/Consultancy, Research grant/Funding (self): Janssen; Non-remunerated activity/ies, Principal Investigator Keynote 189;MISP pembrolizumab in low expressors PD-L1(J. Mazieres: Advisory/Consultancy: Merck; Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy: MSD; Advisory/Consultancy: BMS; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Hengrui; Advisory/Consultancy: Daiichi; Advisory/Consultancy: Boehringer; Advisory/Consultancy, Research grant/Funding (self): Pierre Fabre. M. Reck: Honoraria (self), Honoraria for lectures and consultancy: Amgen; Honoraria (self), Honoraria for lectures and consultancy: AstraZeneca; Honoraria (self), Honoraria for lectures and consultancy: BMS; Honoraria (self), Honoraria for lectures and consultancy: Boehringer Ingelheim; Honoraria (self), Honoraria for lectures and consultancy: Lilly; Honoraria (self), Honoraria for lectures and consultancy: Merck; Honoraria (self), Honoraria for lectures and consultancy: MSD; Honoraria (self), Honoraria for lectures and consultancy: Novartis; Honoraria (self), Honoraria for lectures and consultancy: Pfizer; Honoraria (self), Honoraria for lectures and consultancy: Roche; Honoraria (self), Honoraria for lectures and consultancy: Samsung. R. Bernabe: Research grant/Funding (institution): Roche. I. Diaz Perez: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. W. Sawyer: Full/Part-time employment, Contractor: AstraZeneca. N. Trunova: Shareholder/Stockholder/Stock options, Full/Part-time employment: AstraZeneca. C. Faivre-Finn: Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (self), Travel/Accommodation/Expenses: Elekta. All other authors have declared no conflicts of interest.
Invited Discussant 78MO and 79MO
- R. Soo (Singapore, Singapore)
- R. Soo (Singapore, Singapore)
79MO - PACIFIC-R: real-world characteristics of unresectable Stage III NSCLC patients treated with durvalumab after chemoradiotherapy
- F. McDonald (London, United Kingdom)
- F. McDonald (London, United Kingdom)
- F. Mornex (Lyon, France)
- M. Garassino (Chicago, IL, United States of America)
- A. Filippi (Pavia PV, Italy)
- D. Christoph (Essen, Germany)
- V. Haakensen (Oslo, Norway)
- A. Agbarya (Haifa, Israel)
- M. Van den Heuvel (Amsterdam, Netherlands)
- P. Vercauter (Aalst, Belgium)
- C. Chouaid (Créteil, France)
- E. Pichon (Tours, France)
- S. Siva (Melbourne, VI, Australia)
- L. Steinbusch (Amsterdam, Netherlands)
- I. Peretz (Tel Aviv, Israel)
- B. Solomon (Melbourne, VI, Australia)
- L. Decoster (Brussels, Belgium)
- W. Sawyer (Cambridge, United Kingdom)
- A. Allen (Gaithersburg, MD, United States of America)
- M. Licour (Paris, France)
- N. Girard (Paris, France)
Abstract
Background
The PACIFIC regimen (up to 12 months of durvalumab treatment in pts with unresectable stage III non-small cell lung cancer [NSCLC] who did not progress after platinum-based concurrent chemoradiotherapy [cCRT]) is now standard of care. Insights into durvalumab use outside the clinical trial setting are needed.
Methods
PACIFIC-R (NCT03798535) is a large international, observational study of pts with unresectable Stage III NSCLC who received ≥1 dose of durvalumab (10 mg/kg Q2W) as part of an AstraZeneca-initiated expanded access programme (September 2017–December 2018). Pts must have completed platinum-based chemotherapy (CT) concurrent or sequential to radiotherapy (RT) within the previous 12 weeks without evidence of disease progression. Data will be retrospectively collected up to 5 years after enrolment.
Results
The full analysis set (N = 1155) showed no significant differences in baseline demographics and disease characteristics by PD-L1 expression status (tested pts: ≥1% [n = 574] vs <1% [n = 138]). A majority of pts had received cCRT (n = 893). Pts who had received sequential CRT (sCRT; n = 163) were generally older (37.4% vs 28.4% aged ≥70 years); a higher proportion had larger tumour volume (25.0% vs 15.9% >70 mm). Median total RT dose (overall: 65 Gy) and duration (overall: 1.5 months) reflected local practice. For platinum-based CT regimens, vinorelbine was favoured in France/Germany/UK; paclitaxel in Australia/Israel; and etoposide in Netherlands/Belgium/Norway. Median CT duration ranged from 0.8 to 2.3 months (overall: 1.6 months). Median time of durvalumab start from end of CRT varied from 39 to 89 days (overall: 52 days). Most commonly reported adverse events of special interest (AESIs) in the first 3 months of durvalumab treatment were pneumonitis (10.6%) and endocrinopathies (6.8%), leading to permanent treatment discontinuation in 4.8% and 0.2% of pts, respectively.
Conclusions
Real-world characteristics of PACIFIC-R pts reflect the PACIFIC population (only cCRT was allowed per protocol in PACIFIC). Time to durvalumab start from end of CRT was longer than in PACIFIC (except France: durvalumab start ≤6 weeks from end of CRT per protocol). Permanent discontinuation due to AESIs was infrequent.
Clinical trial identification
NCT03798535.
Editorial acknowledgement
Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Carole Mongin-Bulewski of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca plc.
Funding
AstraZeneca.
Disclosure
F. McDonald: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self): Elekta; Advisory/Consultancy: Accuracy; Research grant/Funding (institution): MSD. M.C. Garassino: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, MISP in Thimic malignancies; Speaker, advisory board: Eli Lilly; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Local PI, Enrollment in clinical Trials in NSCLC; Speaker; advisory board: Otsuka Pharma; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment and Steering Committee in clinical Trials in NSCLC;consulting, advisory boards, lectures;steering committee: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; advisory board: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: Roche; Advisory/Consultancy, Research grant/Funding (self), PI, MISP MISP Sunitinib in thymic malignancies; advisory board: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; Speaker, advisory board: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Institutional Grants; Advisory board; Speaker: Incyte; Advisory/Consultancy: Inivata; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Research grant/Funding (self), PI, Enrollment in clinical Trials Thimic malignancies: Tiziana Sciences; Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Clovis; Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC: Merck Serono; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials in Mesothelioma; advisory board: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), PI, Enrollment in clinical Trials in NSCLC; consulting, advisory boards, lectures; steering committee: MSD; Advisory/Consultancy, Research grant/Funding (self), Local PI, Enrollment and Steering committee in clinical Trials in NSCLC; advisory board: GlaxoSmithKline S.p.A.; Advisory/Consultancy, Research grant/Funding (self), Advisory board; PI, Enrollment in clinical Trials: Sanofi-Aventis; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials; Advisory board; steering committee: Spectrum Pharmaceutcials; Advisory/Consultancy, Research grant/Funding (self), PI, Enrollment in clinical Trials; Advisory board; steering committee: Blueprint Medicine; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Daiichi Sankyo; Research grant/Funding (institution): Merck KGaA; Advisory/Consultancy, Research grant/Funding (self): Janssen; Non-remunerated activity/ies, Principal Investigator Keynote 189;MISP pembrolizumab in low expressors PD-L1(A.R. Filippi: Advisory/Consultancy, Scientific consultancy; advisory board: AstraZeneca; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: MSD. D. Christoph: Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: AstraZeneca; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Boehringer Ingelheim; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Bristol-Myers Squibb; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Chugai; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Merck, Sharp & Dohme; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Novartis; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Pfizer; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Roche; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Takeda; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Bayer. A. Agbarya: Non-remunerated activity/ies, Non-financial support: AstraZeneca. M. Van den Heuvel: Research grant/Funding (self), Research projects, not related to Pacific R: AstraZeneca. C. Chouaid: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Sanofi Aventis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Received fees for attending scientific meetings; speaking; organizing research; consulting within past five years: Amgen. E. Pichon: Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Bristol Myers Squibb; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support: Takeda; Non-remunerated activity/ies, Non-financial support: Merck Serono; Non-remunerated activity/ies, Non-financial support: AstraZeneca; Honoraria (self), Personal fees: Roche. S. Siva: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Speaker fees to institution and travel: AstraZeneca; Research grant/Funding (self), Research grant, un-related: Varian Industries. B. Solomon: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Roche/Genentech; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Bristol Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck. L. Decoster: Research grant/Funding (self), Data monitoring: AstraZeneca; Travel/Accommodation/Expenses, Travel grant: Roche Belgium; Research grant/Funding (self): Boehringer Ingelheim; Travel/Accommodation/Expenses, Travel grant: MSD Belgium. W. Sawyer: Full/Part-time employment: AstraZeneca. M. Licour: Shareholder/Stockholder/Stock options, Full/Part-time employment, Employment/stock options: AstraZeneca. N. Girard: Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support outside the submitted work: AstraZeneca; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support outside the submitted work: BMS; Honoraria (self), Non-remunerated activity/ies, Personal fees and non-financial support outside the submitted work: MSD. All other authors have declared no conflicts of interest.
29MO - Early-stage lung cancer detection by a noninvasive breath test
- M. Qiu (Beijing, China)
- M. Qiu (Beijing, China)
- Z. Zhou (Beijing, China)
- S. Meng (Beijing, China)
- H. Li (Shenzhen, China)
- Q. Li (Shenzhen, China)
- J. Wang (Beijing, China)
Abstract
Background
Breath analyses of volatile organic compounds in exhaled breath is a promising option for cancer detection. To establish a feasible and noninvasive detecting method of lung cancer, we have made substatial improvement to the highly sensitive high-pressure photon ionization time-of-flight mass spectrometry (HPPI-TOFMS). In this study, we investigated the accuracy of a breath test using HPPI-TOFMS to detect lung cancer from healthy controls.
Methods
1000 ml exhaled breath was collected from each participant with air bags. A CO2 sensor was applicated during sample collection to ensure “alveolar air” was collected. Exhaled breath samples were detected by HPPI-TOFMS. Detection model construction was performed by support vector machine (SVM) algorithm.
Results
In total, 139 lung cancer patients and 289 healthy controls were eligible and included in this study. Most lung cancer patients were at early stage (TNM stage I-II, 126/139). All exhaled breath samples were prospectively collected and tested. After clinical outcomes were ascertained, all participants were randomly assigned into the discovery cohort (n = 381) and the blinded validation cohort (n = 47). The discovery cohort was further broken into a training set (n = 286) and a test set (n = 95) to construct and test the detection model. SVM built a detection model that accurately distinguished lung cancer patients from controls in the training set. The detection model reached 92.97 ± 0.046% sensitivity, 96.68 ± 0.022% specificity, and 95.51 ± 1.93% accuracy in the test set after 500 times iterations, which was termed as “BreLC v1.0”. Finally, in the blinded validation cohort (n = 47), BreLC revealed a sensitivity of 100%, a specificity of 92.86%, an accuracy of 95.74%, and an AUC of 0.9586.
| Discovery Cohort | Validation Cohort | |||||
|---|---|---|---|---|---|---|
| Lung cancer | Healthy control | P | Lung cancer | Healthy control | P | |
| Sex | 0.070 | 0.160 | ||||
| Male | 46 (38.3%) | 126 (48.3%) | 9 (47.4%) | 19 (67.9%) | ||
| Female | 74 (61.7%) | 135 (51.7%) | 10 (52.6%) | 9 (32.1%) | ||
| Age | 60.4±10.5 | 55.7±12.1 | <0.001 | 58.3±8.5 | 53.9±8.1 | 0.670 |
| Smoking | 0.963 | 0.188 | ||||
| Ever-smokers | 26 (21.7%) | 56 (21.5%) | 4 (21.1%) | 11 (39.3%) | ||
| Never-smokers | 94 (78.3%) | 205 (78.5%) | 15 (78.9%) | 17 (60.7%) | ||
| Pathology | ||||||
| Ad | 103 (85.8%) | 19 (100%) | ||||
| SCC | 14 (11.7%) | 0 | ||||
| SCLC | 1 (0.8%) | 0 | ||||
| Others | 2 (1.7%) | 0 | ||||
| TNM stage | ||||||
| I | 97 (80.8%) | 17 (89.5%) | ||||
| II | 12 (10.0%) | 0 | ||||
| III | 6 (5.0%) | 1 (5.3%) | ||||
| IV | 1 (0.8%) | 1 (5.3%) |
Conclusions
The breath test with HPPI-TOFMS is feasible and highly accurate for lung cancer detection and might have important implications for future lung cancer screening.
Clinical trial identification
NCT04419207.
Legal entity responsible for the study
Mantang Qiu and Zuli Zhou.
Funding
The National Natural Science Foundation of China.
Disclosure
All authors have declared no conflicts of interest.
62MO - Comparison of lobectomy and sublobar resection for stage IA elderly NSCLC patients (≥70 years): a population-based propensity score matching’s study
- B. Zhang (Tianjin, China)
- B. Zhang (Tianjin, China)
- W. Liu (Tianjin, China)
- D. Ren (Tianjin, China)
- F. Li (Tianjin, China)
- Y. Wang (Tianjin, China)
- D. Huo (Tianjin, China)
- S. Zhu (Tianjin, China)
- J. Chen (Dalian, China)
- Q. Song (Tianjin, China)
- S. Xu (Tianjin, China)
Abstract
Background
To investigate the differences in survival between lobectomy and sublobar resection for elderly stage I non-small cell lung cancer (NSCLC) patients using the Surveillance, Epidemiology, and End Results (SEER) registry.
Methods
The data of stage I elderly NSCLC patients (≥ 70 years) with tumours ≤ 3 cm in diameter were extracted. Propensity-matched analysis was used. Overall survival (OS) and lung cancer-specific survival (LCSS) were compared among the patients after lobectomy and sub-lobar resection. The proportional hazards model was applied to identify multiple prognostic factors.
Results
3,504 patients met criteria after propensity score matching (PSM). Although the OS was better for lobectomy than for sublobar resection in patients with tumours ≤ 3 cm after PSM (p < 0.01), no significant difference in LCSS was identified between the two treatment groups after PSM (p = 0.144). According to subgroups of tumour sizes and histologic types (adenocarcinoma and other carcinomas), there were no significant difference for LCSS between lobectomy and sub-lobar resection (all P > 0.05). As for the squamous cell carcinoma, significant difference was observed in LCSS and OS between lobectomy and sub-lobar resection (P < 0.05). In terms of lymph nodes, the results showed that ≥ 4 regional LNs dissection was no difference in LCSS and OS between the treatment groups (p = 0.132, p = 0.713, respectively). Multivariate Cox regression showed the elder age, poor/undifferentiated grade and a large tumour size were associated with poor LCSS. The sublobar resection was divided into segmentectomy or wedge resection. Regardless of tumour sizes, histologic types and LNs, no significant differences in LCSS were identified among the treatment subgroups (all p > 0.05). Multivariate Cox regression analysis showed the elder age, poor grade and large tumour size were a statistically significant independent factor associated with survival.
Conclusions
In terms of LCSS, lobectomy has no significant advantage over sub-lobar resection in elderly patients with stage IA NSCLC if lymph node assessment is performed adequately. As for the histology of squamous cell carcinoma, lobectomy is still the standard surgical procedure.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
63MO - Safety analysis of durvalumab following stereotactic body radiotherapy (SBRT) in early-stage non-small-cell lung cancer (NSCLC) patients - A first report of a randomized phase II trial (ASTEROID)
- A. Hallqvist (Göteborg, Sweden)
- A. Hallqvist (Göteborg, Sweden)
- H. Koyi (Solna, Sweden)
- L. De Petris (Solna, Sweden)
- K. Lindberg (Solna, Sweden)
- S. Farooqi (Oslo, Norway)
- Å. Helland (Oslo, Norway)
- A. Wikström (Linköping, Sweden)
- M. Johansson (Umeå, Sweden)
- M. Planck (Lund, Sweden)
- L. Lindberg (Luleå, Sweden)
- Ø. Yksnøy (Ålesund, Norway)
- B. Grønberg (Trondheim, Norway)
- N. Helbekkmo (Tromsö, Norway)
- J. Nyman (Göteborg, Sweden)
Abstract
Background
SBRT is the standard treatment for early-stage NSCLC patients that are medically unfit for surgery and is associated with excellent results in terms of local control. However, approximately 30% of patients develop distant metastases over time. Adjuvant chemotherapy is rarely administered because of a lack of data and the fragility of this population. Theoretically, immunotherapy is an attractive option, with less toxicity and a potential synergistic effect in combination with radiation. The ASTEROID trial aims to assess whether durvalumab improves outcomes after SBRT in T1-2N0M0 NSCLC patients. Herein, we present a toxicity report for the first 47 included patients.
Methods
Randomized multicentre open-label phase II study comparing SBRT alone (arm A) in 3–4 fractions with SBRT followed by adjuvant treatment with 1500 mg durvalumab every 4 weeks (arm B). The primary endpoint is time to progression (TTP).
Results
Hitherto, 25 + 22 (arms A + B) patients have been included. The majority were women (66%), 66% had adenocarcinomas, 28% had PS 0, 51% PS 1 and 21% PS 2. The median age was 76 (58–89) years, 98% of the patients were former or current smokers and the mean FEV1 was 1.6 (0.64–4.5) L. The median number of durvalumab infusions were 11 (3–12) for the 24 patients who have completed treatment and 6 (1–12) for all patients included in this primary report. Adverse events (CTCAE v4.0) related to SBRT were reported in 7/25 patients (28%) in arm A and 6/22 (27%) in arm B. They were all grade 1–2 events and encompassed pneumonitis, cough, dyspnoea, skin reactions, fatigue and pain. In arm B 12/22 patients (55%) reported AEs related to durvalumab, mainly grade 1 and 2, where the most common events were skin reactions/rash (45%), pruritus (27%) and thyroid disorders (18%). Two patients experienced grade 3 pneumonitis, and 1 patient grade 3 dyspnoea. Three patients had grade 3 asymptomatic hepatitis and 1 patient had grade 4 asymptomatic increased lipase.
Conclusions
SBRT followed by adjuvant durvalumab appears to be feasible and well tolerated. The trial will continue enrolment as planned to assess the primary endpoint of TTP.
Clinical trial identification
EudraCT: 2016–005225-37 NCT03446547.
Legal entity responsible for the study
Sahlgrenska University Hospital, Gothenburg, Sweden.
Funding
AstraZeneca.
Disclosure
All authors have declared no conflicts of interest.
64MO - Early Experience of Bronchoscopic Transbronchial Microwave Ablation of Lung Nodules in the Hybrid Operating Room
- J. Chan (Sha Tin, Hong Kong PRC)
- J. Chan (Sha Tin, Hong Kong PRC)
- R. Lau (Sha Tin, Hong Kong PRC)
- C. Ng (Sha Tin, Hong Kong PRC)
Abstract
Background
Microwave ablation of lung nodules produces faster and larger ablation zones than other energy sources, while bronchoscopic route of access may avoid pleural-based complications associated with traditional percutaneous access. The combination of both is a novel approach in management of suspicious or malignant lung nodules.
Methods
Lung nodule microwave ablation was performed in hybrid operating room under electromagnetic navigation bronchoscopy guidance. Our center's experience between March 2019 and December 2020 was retrospectively analyzed. Patients had high surgical risks while lung nodules were either proven malignant or radiologically suspicious. Technical feasibility and safety were primarily evaluated.
Results
Total of 44 lung nodules from 36 patients were treated. Mean nodule size was 15.2 mm. Technical success rate was 100%, although some nodules required double ablation for adequate coverage. Mean minimal ablation margin was 5.79 mm. The mean actual ablation zone volume was -20.9% compared to predicted, likely due to significant tissue contraction ranging from 0 to 43%. There was no significant heat sink effect. Mean hospital stay was 1.93 days, and only 2 patients stayed for more than 3 days. Complications included pneumothorax requiring drainage (6.8%), post-ablation reaction (4.5%), pleural effusion (4.5%), hemoptysis (2.3%) and bronchopleural fistula (2.3%). After median follow up of 1 year, none of the nodules had evidence of progression.
Conclusions
Bronchoscopic transbronchial microwave ablation is a novel, feasible and safe technique for treatment of early stage lung cancers, lung metastases or highly suspicious lung nodules.
Legal entity responsible for the study
The authors.
Funding
Research Grants Council (RGC) University Grant Committee Hong Kong, no: 14119019.
Disclosure
R.W. Lau: Advisory/Consultancy: Medtronic; Advisory/Consultancy: Siemens Healthineer. C.S. Ng: Advisory/Consultancy: Johnson & Johnson; Advisory/Consultancy: Medtronic; Advisory/Consultancy: Siemens Healthineer. All other authors have declared no conflicts of interest.
Invited Discussant 29MO, 62MO, 63MO and 64MO
- J. Edwards (Sheffield, United Kingdom)
- J. Edwards (Sheffield, United Kingdom)
Q&A and live discussion
- A. Speakers (, Switzerland)
- A. Speakers (, Switzerland)