PMID- 26279026 OWN - NLM STAT- MEDLINE DCOM- 20151109 LR - 20181202 IS - 1879-355X (Electronic) IS - 0360-3016 (Linking) VI - 93 IP - 1 DP - 2015 Sep 1 TI - Precision Hypofractionated Radiation Therapy in Poor Performing Patients With Non-Small Cell Lung Cancer: Phase 1 Dose Escalation Trial. PG - 72-81 LID - S0360-3016(15)00505-2 [pii] LID - 10.1016/j.ijrobp.2015.05.004 [doi] AB - PURPOSE: Treatment regimens for locally advanced non-small cell lung cancer (NSCLC) give suboptimal clinical outcomes. Technological advancements such as radiation therapy, the backbone of most treatment regimens, may enable more potent and effective therapies. The objective of this study was to escalate radiation therapy to a tumoricidal hypofractionated dose without exceeding the maximally tolerated dose (MTD) in patients with locally advanced NSCLC. METHODS AND MATERIALS: Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy. RESULTS: Fifty-five patients were enrolled: 15 at the 50-Gy, 21 at the 55-Gy, and 19 at the 60-Gy dose levels. A 90-day follow-up was completed in each group without exceeding the MTD. With a median follow-up of 12.5 months, there were 93 grade >/= 3 adverse events (AEs), including 39 deaths, although most AEs were considered related to factors other than radiation therapy. One patient from the 55- and 60-Gy dose groups developed grade >/= 3 esophagitis, and 5, 4, and 4 patients in the respective dose groups experienced grade >/= 3 dyspnea, but only 2 of these AEs were considered likely related to therapy. There was no association between fraction size and toxicity (P = .24). The median overall survival was 6 months with no significant differences between dose levels (P = .59). CONCLUSIONS: Precision hypofractionated radiation therapy consisting of 60 Gy in 15 fractions for locally advanced NSCLC is generally well tolerated. This treatment regimen could provide patients with poor performance status a potent alternative to chemoradiation. This study has implications for the cost effectiveness of lung cancer therapy. Additional studies of long-term safety and efficacy of this therapy are warranted. CI - Copyright (c) 2015 Elsevier Inc. All rights reserved. FAU - Westover, Kenneth D AU - Westover KD AD - Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Loo, Billy W Jr AU - Loo BW Jr AD - Department of Radiation Oncology, Stanford University, Stanford, California. FAU - Gerber, David E AU - Gerber DE AD - Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Iyengar, Puneeth AU - Iyengar P AD - Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Choy, Hak AU - Choy H AD - Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Diehn, Maximilian AU - Diehn M AD - Department of Radiation Oncology, Stanford University, Stanford, California. FAU - Hughes, Randy AU - Hughes R AD - Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Schiller, Joan AU - Schiller J AD - Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Dowell, Jonathan AU - Dowell J AD - Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Wardak, Zabi AU - Wardak Z AD - Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Sher, David AU - Sher D AD - Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois. FAU - Christie, Alana AU - Christie A AD - Department of Clinical Science, Southwestern Medical Center, Dallas, Texas. FAU - Xie, Xian-Jin AU - Xie XJ AD - Department of Clinical Science, Southwestern Medical Center, Dallas, Texas. FAU - Corona, Irma AU - Corona I AD - Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Sharma, Akanksha AU - Sharma A AD - School of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. FAU - Wadsworth, Margaret E AU - Wadsworth ME AD - Radiation Oncology of Mississippi, Jackson, Mississippi. FAU - Timmerman, Robert AU - Timmerman R AD - Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address: Robert.Timmerman@utsouthwestern.edu. LA - eng PT - Clinical Trial, Phase I PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20150509 PL - United States TA - Int J Radiat Oncol Biol Phys JT - International journal of radiation oncology, biology, physics JID - 7603616 SB - IM MH - Adenocarcinoma/mortality/pathology/radiotherapy MH - Adult MH - Aged MH - Carcinoma, Non-Small-Cell Lung/mortality/pathology/*radiotherapy MH - Carcinoma, Squamous Cell/mortality/pathology/radiotherapy MH - Disease Progression MH - *Dose Fractionation, Radiation MH - Female MH - Follow-Up Studies MH - Humans MH - Lung Neoplasms/mortality/pathology/*radiotherapy MH - Male MH - Maximum Tolerated Dose MH - Middle Aged MH - Neoplasm Recurrence, Local/*radiotherapy MH - Neoplasm Staging MH - Radiotherapy Planning, Computer-Assisted/methods MH - Radiotherapy, Conformal/*methods MH - Severity of Illness Index EDAT- 2015/08/19 06:00 MHDA- 2015/11/10 06:00 CRDT- 2015/08/18 06:00 PHST- 2015/01/20 00:00 [received] PHST- 2015/04/29 00:00 [revised] PHST- 2015/05/04 00:00 [accepted] PHST- 2015/08/18 06:00 [entrez] PHST- 2015/08/19 06:00 [pubmed] PHST- 2015/11/10 06:00 [medline] AID - S0360-3016(15)00505-2 [pii] AID - 10.1016/j.ijrobp.2015.05.004 [doi] PST - ppublish SO - Int J Radiat Oncol Biol Phys. 2015 Sep 1;93(1):72-81. doi: 10.1016/j.ijrobp.2015.05.004. Epub 2015 May 9.