Accelerated Hypofractionated Image-Guided vs Conventional Radiotherapy for Patients With Stage II/III Non–Small Cell Lung Cancer and Poor Performance Status

Iyengar, Puneeth; Zhang-Velten, Elizabeth; Court, Laurence E.; Westover, Kenneth D.; Yan, Yulong; Lin, MingDe; Xiong, Zhenyu; Patel, Mehul; Rivera, Douglas; Chang, Joe Y.; Saunders, Mark W.; Shivnani, Anand T.; Lee, Andrew; Hughes, Randall; Gerber, David E.; Dowell, Jonathan E.; Gao, Ang; Heinzerling, J.H.; Liu, Ying; Ahn, Chul; Choy, Hak; Timmerman, Robert

doi:10.1001/jamaoncol.2021.3186

Cited by 50 publications

(35 citation statements)

References 25 publications

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“…193 The same investigator group subsequently conducted a randomized, multi-institution phase III comparison of 60 Gy in 15 versus 30 fractions of image-guided photon radiation therapy in patients ineligible for concurrent chemoradiation or with a Zubrod performance status of 2 or greater. 127 The primary end point was 1-year OS. The trial was closed to accrual when an interim analysis suggested futility at meeting the primary end point.…”

Section: Recommendationsmentioning

confidence: 99%

Management of Stage III Non–Small-Cell Lung Cancer: ASCO Guideline

Daly

Singh

Ismaila

et al. 2022

JCO

124

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PURPOSE To provide evidence-based recommendations to practicing clinicians on management of patients with stage III non–small-cell lung cancer (NSCLC). METHODS An Expert Panel of medical oncology, thoracic surgery, radiation oncology, pulmonary oncology, community oncology, research methodology, and advocacy experts was convened to conduct a literature search, which included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2021. Outcomes of interest included survival, disease-free or recurrence-free survival, and quality of life. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS The literature search identified 127 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS Evidence-based recommendations were developed to address evaluation and staging workup of patients with suspected stage III NSCLC, surgical management, neoadjuvant and adjuvant approaches, and management of patients with unresectable stage III NSCLC. Additional information is available at www.asco.org/thoracic-cancer-guidelines .

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Section: Recommendationsmentioning

confidence: 99%

Management of Stage III Non–Small-Cell Lung Cancer: ASCO Guideline

Daly

Singh

Ismaila

et al. 2022

JCO

124

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“…At a median follow‐up of 8.7 months, the primary end point of 1‐year OS was 37.7% versus 44.6% in the experimental and control arms, respectively. In addition, median PFS/OS was 6.4/8.2 months in the hypofractionation arm and 7.3/10.6 months in the normofractionation arm 12 . Another retrospective analysis from one of the participating centers of the previous study retrospectively analyzed 300 stage III patients with NSCLC treated with either AHRT (arm A, 45.0 Gy/15 fractions) or conventionally fractionated RT (arm B, 60.0‐63.0 Gy; arm C, >63.0 Gy).…”

Section: Discussionmentioning

confidence: 95%

“…In addition, median PFS/OS was 6.4/8.2 months in the hypofractionation arm and 7.3/10.6 months in the normofractionation arm. 12 Another retrospective analysis from one of the participating centers of the previous study retrospectively analyzed 300 stage III patients with NSCLC treated with either AHRT (arm A, 45.0 Gy/15 fractions) or conventionally fractionated RT (arm B, 60.0-63.0 Gy; arm C, >63.0 Gy). Interestingly, despite more patients significantly presenting with adverse risk factors in the AHRT arm (performance status, weight loss, and stage IIIB disease [TNM, 7th edition]), there was no significant benefit in terms of tumor control and OS.…”

Section: Discussionmentioning

confidence: 99%

“…In previous series investigating AHRT alone in locally advanced NSCLC, patients with favorable risk factors were evaluated, 5‐7 as were patients with unfavorable risk factors 8‐11 . More recently, the first randomized trial on AHRT in patients with poor performance status was published 12 . However, there is a knowledge gap in a distinct subpopulation with poor prognostic factors and, importantly, severely limited pulmonary function and reserve (forced expiratory volume in 1 second [FEV 1 ] ≤1 L and/or single‐breath diffusing capacity of the lung for carbon monoxide [DLCO‐SB] ≤40% predicted and/or on long‐term oxygen therapy).…”

Section: Introductionmentioning

confidence: 99%

“…[8][9][10][11] More recently, the first randomized trial on AHRT in patients with poor performance status was published. 12 However, there is a knowledge gap in a distinct subpopulation with poor prognostic Cancer June 15, 2022 factors and, importantly, severely limited pulmonary function and reserve (forced expiratory volume in 1 second [FEV 1 ] ≤1 L and/or single-breath diffusing capacity of the lung for carbon monoxide [DLCO-SB] ≤40% predicted and/or on long-term oxygen therapy). Previously, we demonstrated our initial experience with this protocol.…”

Section: Introductionmentioning

confidence: 99%

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Pooled analysis on image‐guided moderately hypofractionated thoracic irradiation in inoperable node‐positive/recurrent patients with non–small cell lung cancer with poor prognostic factors and severely limited pulmonary function and reserve

Eze

Guggenberger

Schmidt-Hegemann

et al. 2022

Cancer

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BACKGROUND:The objective of this study was to investigate the feasibility and efficacy of image-guided moderately hypofractionated thoracic radiotherapy (hypo-IGRT) in patients with non-small cell lung cancer (NSCLC) with poor performance status and severely limited pulmonary function and reserve. METHODS: Consecutive inoperable patients who had node-positive, stage IIB-IIIC (TNM, 8th edition) or recurrent NSCLC, had an Eastern Cooperative Oncology Group performance status ≥1, and had a forced expiratory volume in 1 second (FEV 1 ) ≤1.0 L, had a single-breath diffusing capacity of the lung for carbon monoxide (DLCO-SB) ≤40% and/or on long-term oxygen therapy were analyzed. All patients received hypofractionated IGRT to a total dose of 42.0 to 49.0 Gy/13 to 16 fractions (2.8-3.5 Gy/fraction) (equivalent dose in 2-Gy fractions/biologically effective dose [α/β = 10] = 45.5-55.1 Gy/54.6-66.2 Gy) alone. Patients were monitored closely for nonhematological toxicity, which was classified per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. RESULTS: Between 2014 and 2021, 47 consecutive patients with a median age of 72 years (range, 52.2-88 years) were treated. At baseline, the median FEV 1 , vital capacity, and DLCO-SB were 1.17 L (range, 0.69-2.84 L), 2.34 L (range, 1.23-3.74 L), and 35% predicted (range, 13.3%-69.0%), respectively. The mean and median planning target volumes were 410.8 cc (SD, 267.1 cc) and 315.4 cc (range, 83.4-1174.1 cc). With a median follow-up of 28.9 months (range, 0.5-90.6 months) after RT, the median progression-free survival (PFS)/overall survival (OS) and 6-and 12-month PFS/OS rates were 10.4 months (95% CI, 7-13.8 months)/18.3 months (95% CI, 9.2-27.4 months), 70%/89.4%, and 38.8%/66%, respectively. Treatment was well tolerated with only 1 case each of grade 3 pneumonitis and esophagitis. No toxicity greater than grade 3 was observed. CONCLUSIONS: Patients with inoperable node-positive NSCLC, a poor performance status, and severely limited lung function can be safely and effectively treated with individualized moderately hypofractionated IGRT. The achieved survival rates for this highly multimorbid group of patients were encouraging.

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Hypofractionated Radiotherapy for Locally Advanced Non–Small Cell Lung Cancer—Does Size Matter?

Ohri

Werner‐Wasik

2022

JAMA Oncol

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In Reply We appreciate the comments from Chen et al on our Research Letter evaluating the inclusion of women in global oncology drug trials over the past 20 years. 1 Our central conclusion was that women were underrepresented in certain tumor types.Chen et al argue that we ought to have adjusted our analysis 1 for the participation to prevalence ratio. We agree that adjustment is needed for the number of people eligible to participate, but prevalence does not capture that. The incidence of a specific tumor indication (eg, second-line metastatic breast cancer or newly diagnosed multiple myeloma) is a better indicator of individuals eligible for frontline therapy and has been used in similar studies. 2,3 Accordingly, we reanalyzed our data 1 using a statistical test to evaluate the difference between female incidence and enrollment. We found that the proportion of women enrolled in colon and thyroid cancer trials were significantly underrepresented. These findings support our conclusion that female enrollment is not proportional to expected rates in colon and thyroid cancer.Finally, Chen et al cite a study that purportedly claimed that women are adequately represented across premarketing and postmarketing studies. 4 However, the study aggregated trials across multiple indications, including female-predominant cancers (breast, cervical, and ovarian). Including multiple trials of female-predominant indications will lead to an overrepresentation of women in the aggregate estimate cited by Chen et al. Looking by disease, the results support those we identified in our study, 1 including the similarity to thyroid cancer, which demonstrated one of the largest disparities in premarketing and postmarketing trials (participation to prevalence ratio, 0.64; 95% CI, 0.60-0.68; and 0.44; 95% CI, 0.72-0.77, respectively).

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Accelerated Hypofractionated Image-Guided vs Conventional Radiotherapy for Patients With Stage II/III Non–Small Cell Lung Cancer and Poor Performance Status

Cited by 50 publications

References 25 publications

Management of Stage III Non–Small-Cell Lung Cancer: ASCO Guideline

Management of Stage III Non–Small-Cell Lung Cancer: ASCO Guideline

Pooled analysis on image‐guided moderately hypofractionated thoracic irradiation in inoperable node‐positive/recurrent patients with non–small cell lung cancer with poor prognostic factors and severely limited pulmonary function and reserve

Hypofractionated Radiotherapy for Locally Advanced Non–Small Cell Lung Cancer—Does Size Matter?

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