Phase II Study of Accelerated Hypofractionated Three-Dimensional Conformal Radiotherapy for Stage T1-3 N0 M0 Non-Small Cell Lung Cancer: NCIC CTG BR.25

Cheung, Patrick; Faria, Sergio; Ahmed, Shahida; Chabot, Pierre; Greenland, Jonathan; Kurien, Elizabeth; Mohamed, Islam; Wright, James R.; Hollenhorst, Helmut; Metz, Catherine de; Campbell, Holly R.; Vu, T. T.; Karvat, Anand; Wai, Elaine S.; Ung, Yee C.; Goss, Glenwood D.; Shepherd, Frances A.; O’Brien, P.; Ding, Keyue; O’Callaghan, Chris

doi:10.1093/jnci/dju164

Cited by 60 publications

(37 citation statements)

References 11 publications

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“…However, our data confirmed that the dominant pattern of relapse in these large tumours is not connected with local failure, as was similarly reported by other authors in both SBRT 24 and hypofractionated studies. 13 However, large tumours were associated with poorer rates of OS, TTP, RF and TTM. Thus, these findings suggest that systemic therapy could be an option for large tumours with concurrent hypofractionated RT.…”

Section: Discussionmentioning

confidence: 99%

“…The National Cancer Institute of Canada (NCIC) Clinical Trials Group BR 35 study 13 revealed a 2-year tumour control rate of 87.4% and a 2-year OS of 68.7% after delivering 60 Gy in 15 fractions using 3D for peripherally located tumours ,5 cm and with Stages T1-3 N0 M0 NSCLC. Furthermore, the Cancer and Leukemia Group B (CALGB) 39904 trial 11 in a Phase I study comprised 39 patients with NSCLC T1-2 N0 M0 ,4 cm, who were treated with increasing hypofractionated RT to a total dose of 70 Gy and with reduced number of fractions.…”

Section: Discussionmentioning

confidence: 99%

“…Some studies of HFRT using various radiation-dose schedules resulted in improved outcomes beyond those achieved with conventionally fractionated RT. [11][12][13] The purpose of this study was to assess the toxicity and clinical outcome of dose-escalation HFRT with 3D RT for medically inoperable early-stage NSCLC.…”

Section: Introductionmentioning

confidence: 99%

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Hypofractionated 3D radiotherapy for inoperable T1-3 N0-1 non-small-cell lung cancer

Mollà

Saez

Ramos

et al. 2016

BJR

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Objective: This study assessed the toxicity and clinical outcomes of three-dimensional (3D) hypofractionated radiotherapy (HFRT) for medically inoperable T1-3 N0-1 non-small-cell lung cancer (NSCLC). Methods: 34 patients with inoperable early-stage NSCLC were treated from August 2008 to April 2013. Prior to enrolment, patients were required to be evaluated by an experienced thoracic surgeon to determine the "operability". All received 57 Gy in 19 fractions followed by escalated doses of 3-Gy fractions, up to a total dose of 66 Gy using a 3D conformal technique. Toxicities were measured using the Common Terminology Criteria for Adverse Effects v. 4.0. Results: The median follow-up was 33 months (7-74 months). Toxicity grades $3 were not observed. Local control (LC) was 80.4% at 2 years, whereas regional control (RC) was 78%. The overall survival (OS), time to progression (TTP) and time to distant metastasis (TTM) at 2 years were 60%, 59% and 80%, respectively. For patients with T1-2 N0 and a tumour size ,45 mm (n 5 19), rates of OS, TTP and TTM at 2 years were 71%, 75% and 94%, respectively. LC and RC at 2 years were 85% and 94%, respectively. Conclusion: HFRT using 3.0-Gy fractions amounting to a total dose of 66 Gy is the recommended dose. A Phase 2 trial is warranted in order to assess the safety and efficacy of this fractionation scheme. Advances in knowledge: HFRT results in a favourable outcome in early-stage lung cancer without the usual restrictions in tumour size and/or location associated with previous treatment methods. No special equipment is required, therefore permitting its application in any centre.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Hypofractionated 3D radiotherapy for inoperable T1-3 N0-1 non-small-cell lung cancer

Mollà

Saez

Ramos

et al. 2016

BJR

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“…The Cancer and Leukemia Group B (CALGB) trial 39904 prospectively evaluated accelerated three-dimensional conformal radiation therapy for delivery of 70 Gy in 17-29 fractions for early stage NSCLC and reported a median survival of 38.5 months and disease relapse rate of 25.6% [12]. A Canadian multi-institutional prospective phase II trial reported very promising 2-year LC rates of 87.4% following 60 Gy in 15 fractions [13]. The largest retrospective Canadian study reported a 2-year LC rate of 76.2% in 118 patients following a total dose of 48-60 Gy in 12-15 fractions, in which most patients received 48 Gy (59.7%) or 52 Gy (37.1%) [8].…”

Section: Discussionmentioning

confidence: 99%

Radiation Therapy Alone in cT1-3N0 Non-small Cell Lung Cancer Patients Who Are Unfit for Surgical Resection or Stereotactic Radiation Therapy: Comparison of Risk-Adaptive Dose Schedules

et al. 2016

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PurposeHigh dose definitive radiation therapy (RT) alone is recommended to patients with cT1-3N0 non-small cell lung cancer, who are unfit for surgery or stereotactic RT. This study was conducted to evaluate the clinical outcomes and cost-effectiveness following RT alone using two different modest hypofractionation dose schemes.Materials and MethodsBetween 2001 and 2014, 124 patients underwent RT alone. From 2001 till 2010, 60 Gy in 20 fractions was delivered to 79 patients (group 1). Since 2011, 60 Gy in 20 fractions (group 2, 20 patients), and 60 Gy in 15 fractions (group 3, 25 patients) were selectively chosen depending on estimated risk of esophagitis.ResultsAt follow-up of 16.7 months, 2-year rates of local control, progression-free survival, and overall survival were 62.6%, 39.1%, and 59.1%, respectively. Overall survival was significantly better in group 3 (p=0.002). In multivariate analyses, cT3 was the most powerful adverse factor affecting clinical outcomes. Incidence and severity of radiation pneumonitis were not different among groups, while no patients developed grade 2 esophagitis in group 3 (p=0.003). Under current Korean Health Insurance Policy, RT cost per person was 22.5% less in group 3 compared with others.ConclusionThe current study demonstrated that 60 Gy in 15 fractions instead of 60 Gy in 20 fractions resulted in comparable clinical outcomes with excellent safety, direct cost saving, and improved convenience to the patients with tumors located at ≥ 1.5 cm from the esophagus.

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“…It has been shown that 60 Gy in 15 fractions can provide excellent local control with minimal toxicity in patients with biopsy-proven T1-3 N0 M0 NSCLC. 22 Palliative Care Studies from Europe as well as the United States have documented a single RT fraction is equivalent to multiple fractions in the treatment of bony metastatic disease. 2,23,24 Unfortunately, despite the data, single-fraction RT is still underutilized in the United States.…”

Section: Lung Cancermentioning

confidence: 99%

Radiation Oncology Practice: Adjusting to a New Reimbursement Model

Konski

Freedman

et al. 2016

JOP

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The move to hypofractionation in the United States will lead to increased pressures on departments to address budget shortfalls resulting from the decrease in per-patient revenue. This may be done through a combination of an increase in patient volume, recognition of the increased skill sets required to deliver hypofractionated radiotherapy, delay in capital purchases, and/or reduction in staff. In a value-based environment, these evolutions should improve the value proposition of radiation oncology over a fee-for-service model.

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Phase II Study of Accelerated Hypofractionated Three-Dimensional Conformal Radiotherapy for Stage T1-3 N0 M0 Non-Small Cell Lung Cancer: NCIC CTG BR.25

Abstract: Conformal radiotherapy to a dose of 60 Gy in 15 fractions resulted in favorable primary tumor control and overall survival rates in patients with T1-3 N0 M0 NSCLC. Severe toxicities were uncommon with this relatively simple treatment technique.

Cited by 60 publications

References 11 publications

Hypofractionated 3D radiotherapy for inoperable T1-3 N0-1 non-small-cell lung cancer

Hypofractionated 3D radiotherapy for inoperable T1-3 N0-1 non-small-cell lung cancer

Radiation Therapy Alone in cT1-3N0 Non-small Cell Lung Cancer Patients Who Are Unfit for Surgical Resection or Stereotactic Radiation Therapy: Comparison of Risk-Adaptive Dose Schedules

Radiation Oncology Practice: Adjusting to a New Reimbursement Model

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