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Shankar Siva
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MA01 - Oligometastatic Disease (ID 114)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Oligometastatic NSCLC
- Presentations: 1
- Now Available
- Moderators:Anne Marie Clasina Dingemans, Matthias Guckenberger
- Coordinates: 9/08/2019, 10:30 - 12:00, Copenhagen (1980)
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MA01.01 - Safety of Pembrolizumab Combined with Stereotactic Ablative Body Radiotherapy (SABR) for Pulmonary Oligometastases (Now Available) (ID 2187)
10:30 - 12:00 | Presenting Author(s): Shankar Siva
- Abstract
- Presentation
Background
Pembrolizumab has demonstrated safety and efficacy in a broad range of tumors. However, safety concerns exist around the combination of pembrolizumab and high dose radiotherapy to the lung, particularly as both have independent risk of pneumonitis. In this interim analysis we assess the safety profile of combination pembrolizumab and SABR to pulmonary oligometastases.
Method
As part of the ongoing prospective dual-institutional RAPPORT clinical trial (clinicaltrials.gov ID NCT02855203), patients with 1-5 oligometastases from renal cell carcinoma were enrolled between Nov 2016- April 2019. All participants had ECOG performance status 0-1, and signed informed consent. Patients with at least 1 lung oligometastasis were included in this analysis. All patients were planned for a single fraction of 20Gy SABR to each lung oligometastasis, followed 5 days (+/-3 days) later by 8 cycles of 200mg i.v. 3-weekly pembrolizumab (total 24 weeks). When SABR dose constraints were not achievable, conventional hypofractionated radiotherapy could be delivered. At least 1 oligometastasis needed to receive SABR. Adverse events (AEs) were recorded using CTCAE V4.03 until 30 days post last dose of pembrolizumab, and late AEs atrributable to SABR for 24 months after SABR.
Result
20 patients with a combined total of 41 lung oligometastases were included in this analysis. The mean age was 61 years, with 15 (75%) male. The number of lung oligometastases were 1 in 9 (45%), 2 in 3 (15%), 3 in 6 (30%), 4 in 2 (10%) patients. SABR was delivered to 39 lung oligometastases (95%) and conventional radiotherapy to 2 oligometastases (5%) using 10 fractions of 3Gy. Twelve patients have completed all eight cycles of pembrolizumab, with five patients having ongoing treatment. Three patients ceased treatment early due to grade 3 pneumonitis (15%) after 3, 6 and 7 cycles of pembrolizumab respectively. These patients had 1, 2 and 1 lung oligometastases, respectively. The worst grade of any treatment related AEs was grade 3 in 4 pts (20%), with 3 attributed to both SABR and pembrolizumab, and 1 atributed to pembrolizumab alone. Three of the four grade 3 events were pneumonitis. A further 3 patients had grade 2 AEs(15%), and 8 patients had grade 1 AEs(40%). There were no grade 4 or 5 adverse events, and five patients (25%) had no treatment related adverse events.
Conclusion
SABR to lung oligometastases in combination with pembrolizumab was well tolerated, with clinically acceptable rates of grade 3 pneumonitis compared to historical rates reported with pembrolizumab monotherapy.
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OA05 - Increasing the Impact of Nursing and Allied Health Professional Interventions in Lung Cancer Care (ID 130)
- Event: WCLC 2019
- Type: Oral Session
- Track: Nursing and Allied Professionals
- Presentations: 1
- Now Available
- Moderators:Dianne Zawisza, Maria Guerin
- Coordinates: 9/08/2019, 15:15 - 16:45, San Francisco (2009)
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OA05.01 - A Prospective Study of Swallowing and Voice Outcomes After Treatment for Small-Cell Lung Cancer (Now Available) (ID 2225)
15:15 - 16:45 | Author(s): Shankar Siva
- Abstract
- Presentation
Background
Dysphagia (difficulty swallowing) and dysphonia (impaired voice) have been identified in patients with lung cancer as being a significant problem. However, research to date has been limited in its measurement and it remains unknown which patients experience dysphagia or dysphonia, and what the impact of these problems are to the patient. The purpose of this study was to identify the prevalence and nature of dysphagia and dysphonia in patients with limited stage SCLC.
Method
A prospective cohort pilot study was conducted on 12 patients receiving chemoradiotherapy for limited-stage SCLC. Data collection included: videofluoroscopy swallowing studies (VFSS) to investigate swallowing physiology, aspiration risk and oesophageal motility disorders; limitations to oral intake; patient-reported swallowing problems; and patient-reported voice problems. Data were collected before treatment and again at one, three and six months post-treatment.
Result
No patient was observed to aspirate, and the pharyngeal swallow was safe and functional in all cases. Three patients exhibited oesophageal motility disorders before treatment, while three more exhibited these disorders at the post-treatment assessments. Oral intake was most compromised one month post-treatment; at this time one patient was tube dependent, two required a single consistency diet and two had a diet requiring special preparation. At all other time-points patients were managing a normal or near-normal diet. Despite an absence of oropharyngeal dysphagia observed on VFSS, three patients reported moderate or severe swallowing difficulties one month post-treatment; these self-reported difficulties were no more than mild at follow-up assessments. Three additional patients reported the onset of moderate or severe swallowing difficulties at three and six months post-treatment. Patients who reported swallowing difficulties at one month post-treatment had all received a mean radiation dose to the oesophagus of ≥15.7Gy and a maximum dose to the oesophagus of ≥42Gy, however these relationships were no longer apparent at three and six months post-treatment. Patient-reported voice difficulties were variable, with the worst scores being reported at one month post-treatment for a subset of patients, who continued to report problems across voice-related physical, functional and emotional domains at three and six months post-treatment.
Conclusion
This is the first time that detailed swallowing and voice outcomes have been reported in patients with SCLC. Although patient numbers are small, this study identified discordance between observed swallowing function and patient-reported problems, which may have significant clinical implications for the management of patients with SCLC, as well as identify important issues for future research.
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P2.17 - Treatment of Early Stage/Localized Disease (ID 189)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.17-21 - A Post-Hoc Analysis of TROG 09.02 (CHISEL) Phase III Trial Investigating Pulmonary Function Changes After SABR and Conformal Radiation Therapy (Now Available) (ID 2203)
10:15 - 18:15 | Author(s): Shankar Siva
- Abstract
Background
The TROG 09.02 (CHISEL) trial compared conventional radiotherapy (CRT) administered over a period of four to six weeks with stereotactic ablative body radiotherapy (SABR).(1) Patients randomised to the SABR arm had superior freedom from local failure and longer overall survival.(1) The aim of this analysis was to assess differences in lung function and spirometry tests between SABR and CRT and describe longitudinal changes in respiratory function.
Method
We conducted a post-hoc analysis of all patients recruited to the CHISEL trial. During this trial patients underwent serial Respiratory Function Tests (RFT) including Forced Expiratory Volume in one second (FEV1), Diffusing capacity of the lungs for carbon monoxide (DLCO), Distance Walked in 6 minutes (SMWT) and Forced Vital Capacity (FVC). These were performed at baseline then 3-6 monthly post-treatment. Patients were assessed per treatment received. Linear regression models were used to compare FEV1, FVC and DLCO between SABR and CRT. Separate models at 3 and 12 months post-treatment were created to assess the two different processes impacting lung function post radiation therapy (acute pneumonitis and chronic fibrosis). Linear regression models were used to assess the association of baseline PFT Measures with decline in respiratory function at 3 and 12 months.
Result
Between December 2009 and June 2015, 101 patients were treated in 11 centres in Australia and New Zealand. 34 patients were treated with CRT and 63 with SABR. On regression analysis at 3 months there was no evidence of a difference between arms in the change from baseline in absolute values of FEV1 (beta 0.037, 95% CI [-0.063, 0.14], p=0.47), DLCO (beta -0.5, 95% CI [-1.4, 0.37], p=0.26) nor forced VC (beta 0.024, 95% CI [-0.17, 0.22], p=0.81). At 12 months there were no differences observed in change from baseline of FEV1 (beta0.031, 95% CI [-0.12, 0.18], p=0.69), DLCO (beta -0.43, 95% CI [-1.7, 0.84], p=0.51) nor forced VC (beta 0.047, 95% CI [-0.28, 0.18], p=0.69) between arms.There was no evidence of a difference in the change from baseline in SMWT (m) between two arms at 3 months (beta 35.9, 95% CI [-10, 82.3], p=0.13).Patients in both arms demonstrated similar deterioration in all RFT parameters with time.
Conclusion
Despite the considerably higher biologically effective doses delivered to the tumour in SABR there was no difference in decline in respiratory function observed between the two groups. This is likely due to the higher integral dose, steep dose gradients and reduced margins possible with SABR relative to CRT.
