Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer

Gregory M. Videtic, Rebecca Paulus, Anurag K. Singh, Joe Y. Chang, William Parker, Kenneth R. Olivier, Robert D. Timmerman, Ritsuko R. Komaki, James J. Urbanic, Kevin L. Stephans, Sue S. Yom, Clifford G. Robinson, Chandra P. Belani, Puneeth Iyengar, Munther I. Ajlouni, Darindra D. Gopaul, Jorge B. Gomez Suescun, Ronald C. McGarry, Hak Choy, Jeffrey D. Bradley

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: To present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34 Gy in 1 fraction versus 48 Gy in 4 fractions. Methods and Materials: This was a phase 2 multicenter study of patients with medically inoperable non-small cell lung cancer with biopsy-proven peripheral T1 or T2 N0M0 tumors, with 1-year toxicity rates as the primary endpoint and selected failure and survival outcomes as secondary endpoints. The study opened in September 2009 and closed in March 2011. Final data were analyzed through May 17, 2018. Results: Eighty-four of 94 patients accrued were eligible for analysis: 39 in arm 1 and 45 in arm 2. Median follow-up time was 4.0 years for all patients and 6.0 years for those alive at analysis. Rates of grade 3 and higher toxicity were 2.6% in arm 1 and 11.1% in arm 2. Median survival times (in years) for 34 Gy and 48 Gy were 4.1 versus 4.6, respectively. Five-year outcomes (95% confidence interval) for 34 Gy and 48 Gy were a primary tumor failure rate of 10.6% (3.3%-23.1%) versus 6.8% (1.7%-16.9%); overall survival of 29.6% (16.2%-44.4%) versus 41.1% (26.6%-55.1%); and progression-free survival of 19.1% (8.5%-33.0%) versus 33.3% (20.2%-47.0%). Distant failure as the sole failure or a component of first failure occurred in 6 patients (37.5%) in the 34 Gy arm and in 7 (41.2%) in the 48 Gy arm. Conclusions: No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 years were similar by arm. A median survival time of 4 years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences.

Original languageEnglish (US)
Pages (from-to)1077-1084
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume103
Issue number5
DOIs
StatePublished - Apr 1 2019

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schedules
Non-Small Cell Lung Carcinoma
lungs
radiation therapy
Appointments and Schedules
Radiotherapy
cancer
Survival
toxicity
tumors
Neoplasms
Multicenter Studies
Disease-Free Survival
progressions
confidence
grade
Confidence Intervals
Biopsy
Lung
intervals

All Science Journal Classification (ASJC) codes

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Videtic, Gregory M. ; Paulus, Rebecca ; Singh, Anurag K. ; Chang, Joe Y. ; Parker, William ; Olivier, Kenneth R. ; Timmerman, Robert D. ; Komaki, Ritsuko R. ; Urbanic, James J. ; Stephans, Kevin L. ; Yom, Sue S. ; Robinson, Clifford G. ; Belani, Chandra P. ; Iyengar, Puneeth ; Ajlouni, Munther I. ; Gopaul, Darindra D. ; Gomez Suescun, Jorge B. ; McGarry, Ronald C. ; Choy, Hak ; Bradley, Jeffrey D. / Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927) : A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer. In: International Journal of Radiation Oncology Biology Physics. 2019 ; Vol. 103, No. 5. pp. 1077-1084.
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title = "Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer",
abstract = "Purpose: To present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34 Gy in 1 fraction versus 48 Gy in 4 fractions. Methods and Materials: This was a phase 2 multicenter study of patients with medically inoperable non-small cell lung cancer with biopsy-proven peripheral T1 or T2 N0M0 tumors, with 1-year toxicity rates as the primary endpoint and selected failure and survival outcomes as secondary endpoints. The study opened in September 2009 and closed in March 2011. Final data were analyzed through May 17, 2018. Results: Eighty-four of 94 patients accrued were eligible for analysis: 39 in arm 1 and 45 in arm 2. Median follow-up time was 4.0 years for all patients and 6.0 years for those alive at analysis. Rates of grade 3 and higher toxicity were 2.6{\%} in arm 1 and 11.1{\%} in arm 2. Median survival times (in years) for 34 Gy and 48 Gy were 4.1 versus 4.6, respectively. Five-year outcomes (95{\%} confidence interval) for 34 Gy and 48 Gy were a primary tumor failure rate of 10.6{\%} (3.3{\%}-23.1{\%}) versus 6.8{\%} (1.7{\%}-16.9{\%}); overall survival of 29.6{\%} (16.2{\%}-44.4{\%}) versus 41.1{\%} (26.6{\%}-55.1{\%}); and progression-free survival of 19.1{\%} (8.5{\%}-33.0{\%}) versus 33.3{\%} (20.2{\%}-47.0{\%}). Distant failure as the sole failure or a component of first failure occurred in 6 patients (37.5{\%}) in the 34 Gy arm and in 7 (41.2{\%}) in the 48 Gy arm. Conclusions: No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 years were similar by arm. A median survival time of 4 years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences.",
author = "Videtic, {Gregory M.} and Rebecca Paulus and Singh, {Anurag K.} and Chang, {Joe Y.} and William Parker and Olivier, {Kenneth R.} and Timmerman, {Robert D.} and Komaki, {Ritsuko R.} and Urbanic, {James J.} and Stephans, {Kevin L.} and Yom, {Sue S.} and Robinson, {Clifford G.} and Belani, {Chandra P.} and Puneeth Iyengar and Ajlouni, {Munther I.} and Gopaul, {Darindra D.} and {Gomez Suescun}, {Jorge B.} and McGarry, {Ronald C.} and Hak Choy and Bradley, {Jeffrey D.}",
year = "2019",
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Videtic, GM, Paulus, R, Singh, AK, Chang, JY, Parker, W, Olivier, KR, Timmerman, RD, Komaki, RR, Urbanic, JJ, Stephans, KL, Yom, SS, Robinson, CG, Belani, CP, Iyengar, P, Ajlouni, MI, Gopaul, DD, Gomez Suescun, JB, McGarry, RC, Choy, H & Bradley, JD 2019, 'Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer', International Journal of Radiation Oncology Biology Physics, vol. 103, no. 5, pp. 1077-1084. https://doi.org/10.1016/j.ijrobp.2018.11.051

Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927) : A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer. / Videtic, Gregory M.; Paulus, Rebecca; Singh, Anurag K.; Chang, Joe Y.; Parker, William; Olivier, Kenneth R.; Timmerman, Robert D.; Komaki, Ritsuko R.; Urbanic, James J.; Stephans, Kevin L.; Yom, Sue S.; Robinson, Clifford G.; Belani, Chandra P.; Iyengar, Puneeth; Ajlouni, Munther I.; Gopaul, Darindra D.; Gomez Suescun, Jorge B.; McGarry, Ronald C.; Choy, Hak; Bradley, Jeffrey D.

In: International Journal of Radiation Oncology Biology Physics, Vol. 103, No. 5, 01.04.2019, p. 1077-1084.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927)

T2 - A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer

AU - Videtic, Gregory M.

AU - Paulus, Rebecca

AU - Singh, Anurag K.

AU - Chang, Joe Y.

AU - Parker, William

AU - Olivier, Kenneth R.

AU - Timmerman, Robert D.

AU - Komaki, Ritsuko R.

AU - Urbanic, James J.

AU - Stephans, Kevin L.

AU - Yom, Sue S.

AU - Robinson, Clifford G.

AU - Belani, Chandra P.

AU - Iyengar, Puneeth

AU - Ajlouni, Munther I.

AU - Gopaul, Darindra D.

AU - Gomez Suescun, Jorge B.

AU - McGarry, Ronald C.

AU - Choy, Hak

AU - Bradley, Jeffrey D.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - Purpose: To present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34 Gy in 1 fraction versus 48 Gy in 4 fractions. Methods and Materials: This was a phase 2 multicenter study of patients with medically inoperable non-small cell lung cancer with biopsy-proven peripheral T1 or T2 N0M0 tumors, with 1-year toxicity rates as the primary endpoint and selected failure and survival outcomes as secondary endpoints. The study opened in September 2009 and closed in March 2011. Final data were analyzed through May 17, 2018. Results: Eighty-four of 94 patients accrued were eligible for analysis: 39 in arm 1 and 45 in arm 2. Median follow-up time was 4.0 years for all patients and 6.0 years for those alive at analysis. Rates of grade 3 and higher toxicity were 2.6% in arm 1 and 11.1% in arm 2. Median survival times (in years) for 34 Gy and 48 Gy were 4.1 versus 4.6, respectively. Five-year outcomes (95% confidence interval) for 34 Gy and 48 Gy were a primary tumor failure rate of 10.6% (3.3%-23.1%) versus 6.8% (1.7%-16.9%); overall survival of 29.6% (16.2%-44.4%) versus 41.1% (26.6%-55.1%); and progression-free survival of 19.1% (8.5%-33.0%) versus 33.3% (20.2%-47.0%). Distant failure as the sole failure or a component of first failure occurred in 6 patients (37.5%) in the 34 Gy arm and in 7 (41.2%) in the 48 Gy arm. Conclusions: No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 years were similar by arm. A median survival time of 4 years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences.

AB - Purpose: To present long-term results of RTOG 0915/NCCTG N0927, a randomized lung stereotactic body radiation therapy trial of 34 Gy in 1 fraction versus 48 Gy in 4 fractions. Methods and Materials: This was a phase 2 multicenter study of patients with medically inoperable non-small cell lung cancer with biopsy-proven peripheral T1 or T2 N0M0 tumors, with 1-year toxicity rates as the primary endpoint and selected failure and survival outcomes as secondary endpoints. The study opened in September 2009 and closed in March 2011. Final data were analyzed through May 17, 2018. Results: Eighty-four of 94 patients accrued were eligible for analysis: 39 in arm 1 and 45 in arm 2. Median follow-up time was 4.0 years for all patients and 6.0 years for those alive at analysis. Rates of grade 3 and higher toxicity were 2.6% in arm 1 and 11.1% in arm 2. Median survival times (in years) for 34 Gy and 48 Gy were 4.1 versus 4.6, respectively. Five-year outcomes (95% confidence interval) for 34 Gy and 48 Gy were a primary tumor failure rate of 10.6% (3.3%-23.1%) versus 6.8% (1.7%-16.9%); overall survival of 29.6% (16.2%-44.4%) versus 41.1% (26.6%-55.1%); and progression-free survival of 19.1% (8.5%-33.0%) versus 33.3% (20.2%-47.0%). Distant failure as the sole failure or a component of first failure occurred in 6 patients (37.5%) in the 34 Gy arm and in 7 (41.2%) in the 48 Gy arm. Conclusions: No excess in late-appearing toxicity was seen in either arm. Primary tumor control rates at 5 years were similar by arm. A median survival time of 4 years for each arm suggests similar efficacy, pending any larger studies appropriately powered to detect survival differences.

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