Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): Study protocol for a randomized controlled trial

Trials

Volumn 17, Issue 1, 2016, Pages

  Yang, Fan ^a   Sui, Xizhao ^a   Chen, Xiuyuan ^a   Zhang, Lixue ^a   Wang, Xun ^a   Wang, Shaodong ^a   Wang, Jun ^a  

^a PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

Author keywords

Elderly; Geriatric assessment; Lobectomy; Lung cancer; Pulmonary function; Sublobar resection; Survival

Indexed keywords

AGED; ARTICLE; CANCER RECURRENCE; COHORT ANALYSIS; CONTROLLED STUDY; DISEASE FREE SURVIVAL; FOLLOW UP; GERIATRIC ASSESSMENT; HOSPITALIZATION; HUMAN; LOBECTOMY; LUNG FUNCTION TEST; LUNG RESECTION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PERIOPERATIVE PERIOD; POSTOPERATIVE PERIOD; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SUBLOBAR RESECTION; SURGICAL MORTALITY; TREATMENT OUTCOME; AGE; CANCER STAGING; CHINA; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPARATIVE STUDY; FEMALE; LUNG TUMOR; MALE; METHODOLOGY; MORTALITY; PATHOLOGY; POSTOPERATIVE COMPLICATION; PROCEDURES; RISK FACTOR; TIME FACTOR;

AGE FACTORS; AGED; CARCINOMA, NON-SMALL-CELL LUNG; CHINA; CLINICAL PROTOCOLS; DISEASE-FREE SURVIVAL; FEMALE; GERIATRIC ASSESSMENT; HUMANS; LUNG NEOPLASMS; MALE; NEOPLASM STAGING; PNEUMONECTOMY; POSTOPERATIVE COMPLICATIONS; PROSPECTIVE STUDIES; QUALITY OF LIFE; RESEARCH DESIGN; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84963750760     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1312-6     Document Type: Article

References (68)

1. Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136:E359-86.
2. Howlader N, Noone AM, Krapcho M. SEER Cancer Statistics Review, 1975-2009, SEER web site. 2012.
3. Owonikoko TK, Ragin CC, Belani CP, Oton AB, Gooding WE, Taioli E, et al. Lung cancer in elderly patients: an analysis of the surveillance, epidemiology, and end results database. J Clin Oncol. 2007;25:5570-7.
4. Cerfolio RJ, Bryant AS. Survival and outcomes of pulmonary resection for non-small cell lung cancer in the elderly: a nested case-control study. Ann Thorac Surg. 2006;82:424-9.
5. O'Rourke MA, Feussner JR, Feigl P, Laszlo J. Age trends of lung cancer stage at diagnosis. Implications for lung cancer screening in the elderly. JAMA. 1987;258:921-6.
6. Weinmann M, Jeremic B, Toomes H, Friedel G, Bamberg M. Treatment of lung cancer in the elderly. Part I: non-small cell lung cancer. Lung Cancer. 2003;39:233-53.
7. Hutchins LF, Unger JM, Crowley JJ, Coltman Jr CA, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341:2061-7.
8. Boffa DJ, Allen MS, Grab JD, Gaissert HA, Harpole DH, Wright CD. Data from The Society of Thoracic Surgeons General Thoracic Surgery database: the surgical management of primary lung tumors. J Thorac Cardiovasc Surg. 2008;135:247-54.
9. Scott WJ, Howington J, Feigenberg S, Movsas B, Pisters K. American College of Chest P. Treatment of non-small cell lung cancer stage I and stage II: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(3 Suppl):234S-42.
10. Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy versus limited resection for T1 N0 non-small cell lung cancer. Lung Cancer Study Group. Ann Thorac Surg. 1995;60:615-22. discussion 22-3.
11. Jaklitsch MT, Mery CM, Audisio RA. The use of surgery to treat lung cancer in elderly patients. Lancet Oncol. 2003;4:463-71.
12. Osaki T, Shirakusa T, Kodate M, Nakanishi R, Mitsudomi T, Ueda H. Surgical treatment of lung cancer in the octogenarian. Ann Thorac Surg. 1994;57:188-92. discussion 92-3.
13. Port JL, Kent M, Korst RJ, Lee PC, Levin MA, Flieder D, et al. Surgical resection for lung cancer in the octogenarian. Chest. 2004;126:733-8.
14. Yamamoto K, Padilla Alarcón J, Calvo Medina V, García-Zarza A, Pastor Guillen J, Blasco Armengod E, et al. Surgical results of stage I non-small cell lung cancer: comparison between elderly and younger patients. Eur J Cardiothorac Surg. 2003;23:21-5.
15. Sawada S, Komori E, Nogami N, Bessho A, Segawa Y, Shinkai T, et al. Advanced age is not correlated with either short-term or long-term postoperative results in lung cancer patients in good clinical condition. Chest. 2005;128:1557-63.
16. Fan J, Wang XJ, Jiang GN, Wang L, Zu XW, Zhou X, et al. Survival and outcomes of surgical treatment of the elderly NSCLC in China: a retrospective matched cohort study. Eur J Surg Oncol. 2007;33:639-43.
17. Sullivan V, Tran T, Holmstrom A, Kuskowski M, Koh P, Rubins JB, et al. Advanced age does not exclude lobectomy for non-small cell lung carcinoma*. Chest. 2005;128:2671-6.
18. Nugent WC, Edney MT, Hammerness PG, Dain BJ, Maurer LH, Rigas JR. Non-small cell lung cancer at the extremes of age: impact on diagnosis and treatment. Ann Thorac Surg. 1997;63:193-7.
19. Damhuis RA, Schutte PR. Resection rates and postoperative mortality in 7,899 patients with lung cancer. Eur Respir J. 1996;9:7-10.
20. Naunheim KS, Kesler KA, D'Orazio SA, Fiore AC, Judd DR. Lung cancer surgery in the octogenarian. Eur J Cardiothorac Surg. 1994;8:453-6.
21. Dominguez-Ventura A, Cassivi SD, Allen MS, Wigle DA, Nichols FC, Pairolero PC, et al. Lung cancer in octogenarians: factors affecting long-term survival following resection. Eur J Cardiothorac Surg. 2007;32:370-4.
22. Rueth NM, Parsons HM, Habermann EB, Groth SS, Virnig BA, Tuttle TM, et al. Surgical treatment of lung cancer: predicting postoperative morbidity in the elderly population. J Thorac Cardiovasc Surg. 2012;143:1314-23.
23. Groth SS, Rueth NM, Hodges JS, Habermann EB, Andrade RS, D'Cunha J, et al. Conditional cancer-specific versus cardiovascular-specific survival after lobectomy for stage I non-small cell lung cancer. Ann Thorac Surg. 2010;90:375-82.
24. Mery CM, Pappas AN, Bueno R, Colson YL, Linden P, Sugarbaker DJ, et al. Similar long-term survival of elderly patients with non-small cell lung cancer treated with lobectomy or wedge resection within the surveillance, epidemiology, and end results database. Chest. 2005;128:237-45.
25. Kilic A, Schuchert MJ, Pettiford BL, Pennathur A, Landreneau JR, Landreneau JP, et al. Anatomic segmentectomy for stage I non-small cell lung cancer in the elderly. Ann Thorac Surg. 2009;87:1662-6.
26. Okami J, Ito Y, Higashiyama M, Nakayama T, Tokunaga T, Maeda J, et al. Sublobar resection provides an equivalent survival after lobectomy in elderly patients with early lung cancer. Ann Thorac Surg. 2010;90:1651-6.
27. Harada H, Okada M, Sakamoto T, Matsuoka H, Tsubota N. Functional advantage after radical segmentectomy versus lobectomy for lung cancer. Ann Thorac Surg. 2005;80:2041-5.
28. Takizawa T, Haga M, Yagi N, Terashima M, Uehara H, Yokoyama A, et al. Pulmonary function after segmentectomy for small peripheral carcinoma of the lung. J Thorac Cardiovasc Surg. 1999;118:536-41.
29. Travis WD, Brambilla E, Noguchi M, Nicholson AG, Geisinger KR, Yatabe Y, et al. International association for the study of lung cancer/american thoracic society/european respiratory society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol. 2011;6:244-85.
30. Yourman LC, Lee SJ, Schonberg MA, Widera EW, Smith AK. Prognostic indices for older adults: a systematic review. JAMA. 2012;307:182-92.
31. Luciani A, Ascione G, Bertuzzi C, Marussi D, Codeca C, Di Maria G, et al. Detecting disabilities in older patients with cancer: comparison between comprehensive geriatric assessment and vulnerable elders survey-13. J Clin Oncol. 2010;28:2046-50.
32. Mohile SG, Bylow K, Dale W, Dignam J, Martin K, Petrylak DP, et al. A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation. Cancer. 2007;109:802-10.
33. van den Berg LL, Klinkenberg TJ, Groen HJ, Widder J. Patterns of recurrence and survival after surgery or stereotactic radiotherapy for early stage NSCLC. J Thorac Oncol. 2015;10:826-31.
34. Crabtree TD, Puri V, Robinson C, Bradley J, Broderick S, Patterson GA, et al. Analysis of first recurrence and survival in patients with stage I non-small cell lung cancer treated with surgical resection or stereotactic radiation therapy. J Thorac Cardiovasc Surg. 2014;147:1183-91.
35. Ochsner A, Debakey M. Primary pulmonary malignancy. Treatment by total pneumonectomy. Analysis of 79 collected cases and presentation of 7 personal cases. Surg Gynecol Obstet. 1939;68:435.
36. Cahan WG. Radical lobectomy. J Thorac Cardiovasc Surg. 1960;39:555-72.
37. Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, et al. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010;40:271-4.
38. Carr SR, Schuchert MJ, Pennathur A, Wilson DO, Siegfried JM, Luketich JD, et al. Impact of tumor size on outcomes after anatomic lung resection for stage 1A non-small cell lung cancer based on the current staging system. J Thorac Cardiovasc Surg. 2012;143:390-7.
39. El-Sherif A, Fernando HC, Santos R, Pettiford B, Luketich JD, Close JM, et al. Margin and local recurrence after sublobar resection of non-small cell lung cancer. Ann Surg Oncol. 2007;14:2400-5.
40. Fernando HC, Santos RS, Benfield JR, Grannis FW, Keenan RJ, Luketich JD, et al. Lobar and sublobar resection with and without brachytherapy for small stage IA non-small cell lung cancer. J Thorac Cardiovasc Surg. 2005;129:261-7.
41. Hamatake D, Yoshida Y, Miyahara S, Yamashita S, Shiraishi T, Iwasaki A. Surgical outcomes of lung cancer measuring less than 1 cm in diameter. Interact Cardiovasc Thorac Surg. 2012;15:854-8.
42. Kates M, Swanson S, Wisnivesky JP. Survival following lobectomy and limited resection for the treatment of stage I non-small cell lung cancer < =1 cm in size: a review of SEER data. Chest. 2011;139:491-6.
43. Keenan RJ, Landreneau RJ, Maley Jr RH, Singh D, Macherey R, Bartley S, et al. Segmental resection spares pulmonary function in patients with stage I lung cancer. Ann Thorac Surg. 2004;78:228-33.
44. Kodama K, Doi O, Higashiyama M, Yokouchi H. Intentional limited resection for selected patients with T1 N0 M0 non-small-cell lung cancer: a single-institution study. J Thorac Cardiovasc Surg. 1997;114:347-53.
45. Koike T, Yamato Y, Yoshiya K, Shimoyama T, Suzuki R. Intentional limited pulmonary resection for peripheral T1 N0 M0 small-sized lung cancer. J Thorac Cardiovasc Surg. 2003;125:924-8.
46. Kraev A, Rassias D, Vetto J, Torosoff M, Ravichandran P, Clement C, et al. Wedge resection vs lobectomy: 10-year survival in stage I primary lung cancer. Chest. 2007;131:136-40.
47. Landreneau RJ, Sugarbaker DJ, Mack MJ, Hazelrigg SR, Luketich JD, Fetterman L, et al. Wedge resection versus lobectomy for stage I (T1 N0 M0) non-small-cell lung cancer. J Thorac Cardiovasc Surg. 1997;113:691-8. discussion 8-700.
48. Martin-Ucar AE, Nakas A, Pilling JE, West KJ, Waller DA. A case-matched study of anatomical segmentectomy versus lobectomy for stage I lung cancer in high-risk patients. Eur J Cardiothorac Surg. 2005;27:675-9.
49. Miller DL, Rowland CM, Deschamps C, Allen MS, Trastek VF, Pairolero PC. Surgical treatment of non-small cell lung cancer 1 cm or less in diameter. Ann Thorac Surg. 2002;73:1545-50. discussion 50-1.
50. Nakamura H, Taniguchi Y, Miwa K, Adachi Y, Fujioka S, Haruki T, et al. Comparison of the surgical outcomes of thoracoscopic lobectomy, segmentectomy, and wedge resection for clinical stage I non-small cell lung cancer. Thorac Cardiovasc Surg. 2011;59:137-41.
51. Okada M. Radical sublobar resection via hybrid video-assisted thoracic surgery (VATS) for small-sized non-small cell lung cancer. Kyobu Geka. 2006;59(8 Suppl):724-9.
52. Okada M, Nishio W, Sakamoto T, Uchino K, Yuki T, Nakagawa A, et al. Effect of tumor size on prognosis in patients with non-small cell lung cancer: the role of segmentectomy as a type of lesser resection. J Thorac Cardiovasc Surg. 2005;129:87-93.
53. Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001;71:956-60. discussion 61.
54. Okumura M, Goto M, Ideguchi K, Tamura M, Sasaki H, Tanaka H, et al. Factors associated with outcome of segmentectomy for non-small cell lung cancer: long-term follow-up study at a single institution in Japan. Lung Cancer. 2007;58:231-7.
55. Schuchert MJ, Pettiford BL, Keeley S, D'Amato TA, Kilic A, Close J, et al. Anatomic segmentectomy in the treatment of stage I non-small cell lung cancer. Ann Thorac Surg. 2007;84:926-32.
56. Sienel W, Dango S, Kirschbaum A, Cucuruz B, Horth W, Stremmel C, et al. Sublobar resections in stage IA non-small cell lung cancer: segmentectomies result in significantly better cancer-related survival than wedge resections. Eur J Cardiothorac Surg. 2008;33:728-34.
57. Warren WH, Faber LP. Segmentectomy versus lobectomy in patients with stage I pulmonary carcinoma. Five-year survival and patterns of intrathoracic recurrence. J Thorac Cardiovasc Surg. 1994;107:1087-93. discussion 93-4.
58. Whitson BA, Groth SS, Andrade RS, Maddaus MA, Habermann EB, D'Cunha J. Survival after lobectomy versus segmentectomy for stage I non-small cell lung cancer: a population-based analysis. Ann Thorac Surg. 2011;92:1943-50.
59. Yamashita S, Chujo M, Kawano Y, Miyawaki M, Tokuishi K, Anami K, et al. Clinical impact of segmentectomy compared with lobectomy under complete video-assisted thoracic surgery in the treatment of stage I non-small cell lung cancer. J Surg Res. 2011;166:46-51.
60. Yendamuri S, Sharma R, Demmy M, Groman A, Hennon M, Dexter E, et al. Temporal trends in outcomes following sublobar and lobar resections for small (
61. Zhong C, Fang W, Mao T, Yao F, Chen W, Hu D. Comparison of thoracoscopic segmentectomy and thoracoscopic lobectomy for small-sized stage IA lung cancer. Ann Thorac Surg. 2012;94:362-7.
62. Read RC, Yoder G, Schaeffer RC. Survival after conservative resection for T1 N0 M0 non-small cell lung cancer. Ann Thorac Surg. 1990;49:391-8. discussion 9-400.
63. Altorki N, Keenan R, Bauer T, Scalzetti E, Demmy T, Kohman L, et al. CALGB 140503/Endorsed study: "A phase III randomized trial of lobectomy versus sublobar resection for small (<2 cm) peripheral non-small cell lung cancer".
64. Lee SJ, Lindquist K, Segal MR, Covinsky KE. Development and validation of a prognostic index for 4-year mortality in older adults. JAMA. 2006;295:801-8.
65. Extermann M, Hurria A. Comprehensive geriatric assessment for older patients with cancer. J Clin Oncol. 2007;25:1824-31.
66. Hurria A, Cirrincione CT, Muss HB, Kornblith AB, Barry W, Artz AS, et al. Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol. 2011;29:1290-6.
67. Audisio RA, Gennari R, Sunouchi K, Nair HR, Sestini A, Pope D, et al. Preoperative assessment of cancer in elderly patients: a pilot study. Support Cancer Ther. 2003;1:55-60.
68. Herth FJ, Krasnik M, Kahn N, Eberhardt R, Ernst A. Combined endoscopic-endobronchial ultrasound-guided fine-needle aspiration of mediastinal lymph nodes through a single bronchoscope in 150 patients with suspected lung cancer. Chest. 2010;138:790-4.