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S.H. Kim
Moderator of
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OA 01 - The New Aspect of Radiation Therapy (ID 652)
- Event: WCLC 2017
- Type: Oral
- Track: Radiotherapy
- Presentations: 8
- Moderators:M. Hiraoka, S.H. Kim
- Coordinates: 10/16/2017, 11:00 - 12:30, F201 + F202 (Annex Hall)
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OA 01.01 - A Randomized Trial of SABR vs Conventional Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: TROG 09.02 (CHISEL) (ID 8628)
11:00 - 11:10 | Presenting Author(s): David L Ball | Author(s): T. Mai, S.K. Vinod, S. Babington, J.D. Ruben, T. Kron, B. Chesson, A. Herschtal, A. Rezo, C. Elder, M. Skala, A. Wirth, G. Wheeler, A. Lim, M. Vanevski, M. Shaw
- Abstract
- Presentation
Background:
Although stereotactic ablative body radiotherapy (SABR) is now well established as a treatment for stage I non-small cell lung cancer (NSCLC), there is limited evidence that it is as or more effective than conventional fully fractionated radiotherapy (CRT). We conducted a randomized trial to determine if SABR results in longer time to local failure than CRT.
Method:
This was a multicentre trial of the Trans-Tasman Radiation Oncology Group (TROG) and Australasian Lung Cancer Trials Group, registration number NCT01014130. Patients were eligible if they had biopsy proven stage I (T1- T2a N0M0) NSCLC based on PET and were medically inoperable or refused surgery. Patients had to be performance status ECOG 0 or 1, and the tumor had to be at least 2 cm or more from the bifurcation of the lobar bronchus. Patients were randomized 2:1 to SABR (54 Gy in 3 fractions, or 48 Gy in 4 fractions, depending on proximity to the chest wall, to the isodose covering the PTV) or to CRT (66 Gy in 33 fractions or 50 Gy in 20 fractions). The primary objective was to compare time to local failure between arms. Assuming that the rate of local failure at 2 years would be 10% in patients randomized to SABR versus 30% in patients randomized to CRT, 100 patients were required. All living patients were followed for a minimum of 2 years. Analysis was based on the intention to treat principle. Funding: In Australia: Grant #1060822 was awarded through Cancer Australia. In New Zealand, The Cancer Society of New Zealand and the Genesis Oncology Trust.
Result:
Between 12/09 and 6/15, 101 patients were enrolled. There were 56 males and 45 females with a median age of 74 years (range 55-89), ECOG performance status – 28 were 0, 71 were 1 and 1 was 2. TNM stage was T1N0M0 in 71 and T2aN0M0 in 30. Sixty six patients were randomized to SABR and 35 patients to CRT. Patients randomized to SABR had superior freedom from local failure (HR = 0.29, 95% CI 0.130, 0.662, P=0.002) and longer overall survival (HR = 0.51, 95% CI 0.51, 0.911, P=0.020). Worst toxicities by arm were: CRT grade 3, 2 patients; SABR grade 4, 1 patient and grade 3, 9 patients.
Conclusion:
In patients with inoperable stage I NSCLC, compared with CRT, SABR resulted in superior freedom from local failure and was associated with an improvement in overall survival.
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OA 01.02 - Stereotactic Radiotherapy as Salvage Treatment After Surgery and Curative Intended Radiotherapy for Patients with NSCLC (ID 9618)
11:10 - 11:20 | Presenting Author(s): Olfred Hansen | Author(s): C. Kristiansen, Stefan Starup Jeppesen, T.B. Nielsen, T. Schytte, M. Nielsen
- Abstract
- Presentation
Background:
Stereotactic radiotherapy (SBRT) is an efficient treatment for early stages of inoperable NSCLC. SBRT may, however, also be used as salvage treatment for recurrent disease. This retrospective study reports and compares the outcome of patients initially treated with surgery and patients initially treated with curative radiotherapy (RT).
Method:
All cases of NSCLC treated with RT with curative intent at our institution are prospectively recorded. We here report the results of 114 cases treated at our institution July 2009 to June 2016 with SBRT as salvage therapy. The doses used for peripheral located tumors have been 45-66 Gy (central doses) in 3 fractions (F) while centrally located tumors have been treated with 50-78.4 Gy/ 5-8 F. The patients have been treated with IMRT or VMAT. A group of 80 patients had surgery initially (Surg-Grp): Resection 19 (24%), lobectomy 56 (70%), bi-lobectomy 1 (1%), and pneumonectomy 4 (5%). Another group of 34 patients was initially treated with RT (RT-Grp): SBRT 30 (88%) and conformal chemo-RT 4 (12%). All patients had more than 1 year of potential follow-up.
Result:The patient characteristics
The median, 1, 2, 3, and 4 year overall survival was 50.5 mo, 85%, 72%, 59%, and 59 % in the Surg-Grp and 31.3 mo., 71%, 55%, 46%, and 46% in the RT-Grp, (p=.13).Surg-Grp RT-Grp p-value Age (yr.) 72.6 (55.1; 89.3) 71.7 (53.5; 87.1) 0.56 Female /Male 45 / 35 18 /16 0.91 PS 0-1 55 (69%) 15 (44%) PS 2 21 (26%) 15 (44%) PS 3 4 (5%) 4 (12%) Median FEV1 (L/sec) 1.54 (.39-2.72) 1.37 (.42-2.75) 0.59 Time from initial treatment to salvage treatment (mo) 22.4 (0.6; 272) 20.7 (4.4; 100) Salvage RT 45 Gy/3 F 10 (13%) 9 (26%) 66 Gy/3 F 54 (68%) 18 (53%) 50 Gy /5 F 3 (4%) 0 78.4 Gy /8 F 13 (16%) 7 (21%)
Conclusion:
SBRT gives excellent survival used as salvage therapy after surgery and curative intended radiotherapy.
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OA 01.03 - Patterns of Change in High-Risk Radiological Features in Patients without Local Recurrence after SABR for Early-Stage NSCLC (ID 9185)
11:20 - 11:30 | Presenting Author(s): Merle Ilona Ronden
- Abstract
- Presentation
Background:
Five-year local control rates in early-stage NSCLC following stereotactic ablative radiotherapy (SABR) are approximately 90%. However, the resulting focal fibrosis can be difficult to distinguish from tumor recurrences. We investigated the incidence, and patterns of change in previously reported high-risk radiological features (HRF’s), in patients who were known to have no local recurrence.
Method:
Patients treated using volumetric modulated arc therapy SABR were eligible if follow-up CT-scans were available for at least 2 years. Five clinicians who were unaware of clinical outcomes scored the following HRF’s on CT-scans: enlarging opacity(EO), sequential enlarging opacity(SE), enlarging opacity after 12 months(EO12), bulging margin(BM), loss of linear margins(LOM), cranio-caudal growth(CCG) and loss of air bronchogram(LOB). CT-scans were reviewed at a workstation using in-house plugin customized for ClearCanvas (Synaptive Medical, Toronto, Canada). After each review, clinicians recommended follow-up procedures based on previously published recommendations.
Result:
In 88 patients (747 CT-scans) evaluated, the HRF’s most frequently recorded by ≥3 observers on at least one follow-up CT-scan were EO (64.8%), EO12 (50.0%) and SE (13.6%). Cumulative mean incidence rates of each HRF per category are displayed (figure). Fifty-six patients developed EO in the first year, and 46 of these patients developed subsequent EO12. In 76 patients who developed EO12, 30 had no EO previously. The presence of ≥3 HRF’s have been associated with recurrences, and this was observed in 20 patients. When HRF’s were identified, clinicians indicated that they were either very certain (mean: 37.2%, range: 11.9-70.4%) or moderately certain (mean: 51.2%, range: 26.5-87.1%) about the presence of this feature. In routine care, only 6 patients underwent PET-scans because of a suspected local recurrence, and 4 underwent an attempt at biopsy. Figure 1
Conclusion:
Although HRF’s on CT-scan develop in more than 50% of patients without local recurrence after SABR, only 23% had ≥3 HRF’s.
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OA 01.04 - Discussant - OA 01.01, 01.02, OA 01.03 (ID 10765)
11:30 - 11:45 | Presenting Author(s): Jin Hee Kim
- Abstract
- Presentation
Abstract not provided
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OA 01.05 - Analysis of Radiotherapy Quality Assurance Data for the Convert Trial - Does Non-Compliance to Protocol Affect Survival? (ID 10117)
11:45 - 11:55 | Presenting Author(s): Elena Wilson | Author(s): N. Groom, Corinne Faivre-Finn
- Abstract
- Presentation
Background:
The CONVERT Trial is a multicentre phase III study which recruited 547 patients with limited-stage SCLC from April 2008 to November 2013. Patients were randomised to receive once daily (66Gy in 33 fractions) or twice daily (45Gy in 30 fractions) radiotherapy concurrently with chemotherapy. The primary endpoint was overall survival. This study investigates the effect of non-compliance to radiotherapy protocol on survival for the CONVERT Trial.
Method:
489/557 received chemo-radiotherapy according to protocol. As part of the CONVERT trial quality assurance (QA) programme, 94 patient datasets (19.2%) treated with concurrent chemoradiotherapy (n=489) were reviewed and deviations from protocol were categorised as acceptable, acceptable variation and unacceptable variation using the Global Harmonisation Group (GHG) variation definitions. Organ at risk outlining (heart, spinal canal and lung minus planning target volume (PTV)), target delineation and margins applied, PTV coverage, treatment planning technique and radiotherapy treatment time were reviewed and classified according to the GHG definitions. A multiplicative factor (F) was calculated for each treatment plan, based on the GHG definitions. A low factor indicates a low number of protocol deviations. Protocol deviations were correlated with survival and number of patients recruited per centre.
Result:
94/489 patients were included in this analysis (19.2% of the randomised patients). The median number of patients recruited per centre was 6 (range 1-109). Protocol deviations were categorised as acceptable (57.6%), acceptable variation (23.3%) or unacceptable variation (19.1%). Amongst the unacceptable variations the PTV coverage was the most common deviation to protocol. In these 71 patients (75.5%) the dose distribution within the PTV was greater than 7% of the prescribed dose. Patients with increasing number of organ at risk outlining protocol deviations and with an increase in the multiplicative factor (F) had a lower survival. Further details will be presented at the meeting including survival in the 3 GHG categories. Centres recruiting >25 patients were found to have a lower number of protocol deviations (median 2, range 2-3) compared with centres recruiting fewer than 25 patients (median 3, range 0-4.5), and were most likely to delineate organs at risk correctly.
Conclusion:
High recruiting centres are most likely to comply with a trial protocol. Overall survival was affected by the number and type of protocol deviations, highlighting the importance of a robust trial QA programme in prospective radiotherapy trials.
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OA 01.06 - Radiation Therapy is Associated with an Increased Incidence of Cardiac Events in Small Cell Lung Cancer Patients (ID 8469)
11:55 - 12:05 | Presenting Author(s): Matthew Jeffrey Ferris | Author(s): R. Jiang, K. Ward, Suresh S Ramalingam, M. Behera, Kristin A Higgins
- Abstract
- Presentation
Background:
Radiation (RT) dose to the heart was a predictor of inferior overall survival (OS) in the non-small cell lung cancer trial RTOG 0617, but little data quantifies cardiac morbidity for small cell lung cancer (SCLC) patients treated with RT.
Method:
The Surveillance, Epidemiology, and End Results (SEER) Program database and Medicare claims data were queried to establish rates of cardiac events (CE) among SCLC patients treated with chemotherapy (CTX) +/- RT. CE were defined as any new cardiac diagnosis including ischemic disease, cardiomyopathy, dysrhythmia, heart failure, and pericarditis. Chronic/pre-existing diagnoses were not counted as events. CTX-only patients were matched to CTX + RT patients to account for start date of RT. Second phase of propensity score matching (PSM) balanced demographical and clinical differences. Multivariate analysis (MVA) determined effect of tumor and RT covariates on CE and OS. Kaplan-Meier and cumulative incidence (CI) function curves were generated.
Result:
From 2000 – 2011, 7,060 patients were available: 2,892 (40.9%) limited-stage and 4,168 (59.0%) extensive-stage. As expected, CTX + RT patients had better OS (p < 0.001). OS for the CTX + RT and CTX-only groups: 35.0 vs. 21.4% at 12 months, and 6.6 vs 2.3% at 60 months, respectively. RT was associated with CE (p = 0.008), with CI as follows for the CTX + RT and CTX-only groups: 36.4 vs. 35.4% at 12 months, and 44.1 vs 39.0% at 60 months, respectively. MVA demonstrated higher hazard ratio of CE for extensive-stage patients (p < 0.001), black race (p < 0.001), and increased Charlson-Deyo score (p = 0.001). After PSM, 5,286 patients were included. Again, CTX + RT patients had better OS (p < 0.0001). OS for the CTX + RT and CTX-only groups: 30.6 vs. 22.5% at 12 months, and 5.3 vs 2.7% at 60 months, respectively. RT was still associated with CE (p = 0.033) after PSM, with CI of CE for the CTX + RT and CTX-only groups: 36.3 vs. 34.8% at 12 months, and 43.0 vs 38.6% at 60 months, respectively. Tumor laterality (p = 0.84) and RT modality (p = 0.62) were not associated with CE, though low numbers were treated with intensity-modulated versus 3D conformal RT (1:15 ratio).
Conclusion:
In this large database study we demonstrated RT is associated with an absolute increase in the rate of CE at 5-years of approximately 5%. Further evaluation of cardiac sparing radiation techniques should be evaluated for patients with SCLC.
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OA 01.07 - Tracking Major Symptom Burden from Chemotherapy Concurrent with 3D vs. IMRT vs. Proton Beam Radiotherapy for NSCLC (ID 9443)
12:05 - 12:15 | Presenting Author(s): Qiuling Shi | Author(s): X.S. Wang, Z. Liao, George R. Simon, C.S. Cleeland
- Abstract
- Presentation
Background:
During standard concurrent chemoradiotherapy (CRT), patients with NSCLC often report severe symptoms that should be routinely assessed and managed. According to the United States FDA specified standards, patient-reported outcome (PRO) instruments used in clinical trials should have good measurement properties of reliability, validity, and the ability to detect change. This quantitative study used a validated PRO symptom-assessment tool, the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), to compare a cluster of CRT-related symptoms in NSCLC patients receiving CRT, and to investigate the sensitivity of a composite score of these symptoms.
Method:
We enrolled patients with locally advanced NSCLC (n=118) who underwent intensity-modulated radiation therapy (IMRT, n=33), 3-dimensional conformal radiation therapy (3DCRT, n=22), or proton-beam therapy (PBT, n=63). Patients completed the MDASI-LC weekly for up to 12 weeks. Two criteria used for item selection to form a subscale for CRT-related symptoms: MDASI-LC items rated 4-10 in >25% of observations, and that increased significantly during therapy (by mixed-effect models). A CRT-symptom score (MDASI-LC-CRT) was generated by averaging scores from those symptoms. The MDASI-LC-CRT’s responsiveness to treatment was examined by within-person change over time and effect size (ES) statistics.
Result:
Six symptoms—pain, fatigue, drowsiness, lack of appetite, sore throat, coughing—were identified as the most-severe CRT-related symptoms during and after therapy. Before CRT, MDASI-LC-CRT scores did not differ by treatment (3DCRT 2.2±1.8, IMRT 1.6±1.5, PBT 1.8±1.7, p=0.329). At the end of CRT, MDASI-LC-CRT was highest for 3DCRT (4.85±2.40), followed by IMRT (3.18±1.85) and PBT (2.29±1.65). A large ES (1.24) was found for 3DCRT vs. PBT; medium ES were found for 3DCRT vs. IMRT (0.78) and IMRT vs. PBT (0.51). The ES for pre-CRT vs. post-CRT difference (1.8±1.7 vs. 3.0±2.1) was medium (0.63) for all patients, large for 3DCRT (1.25) and IMRT (0.93), and small for PBT (0.28). The MDASI-LC-CRT score increased significantly over treatment (estimated weekly increase=0.21, p<0.0001), peaking at week 7 (95%CL=6.2-7.8, p<.0001) and then decreasing to week 12 (est=0.18, p=0.001). Significantly larger weekly increase was reported by 3DCRT and IMRT patients, compared with PBT patients (all p<0.0001).
Conclusion:
The MDASI-LC-CRT is a sensitive indicator of dynamic change in major symptom burden during CRT. This subscale could be routinely used for symptom monitoring while patients are going through CRT and appropriate supportive measures could be instituted early. PBT was the best tolerated of the radiation modalities when given concurrently with chemotherapy with the least worsening of symptoms over the CRT period.
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OA 01.08 - Discussant - OA 01.05, OA 01.06, OA 01.07 (ID 10840)
12:15 - 12:30 | Presenting Author(s): Yukinori Matsuo
- Abstract
- Presentation
Abstract not provided
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