1
|
Ferlay J, Soerjomataram I, Ervik M,
Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D and
Bray F: GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality
Worldwide: IARC CancerBase No. 11 (Internet). International Agency
for Research on Cancer; Lyon, France: 2013, http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed March 5, 2014
|
2
|
Non-small Cell Lung Cancer Collaborative
Group. Chemotherapy in non-small cell lung cancer: A meta-analysis
using updated data on individual patients from 52 randomised
clinical trials. BMJ. 311:899–909. 1995. View Article : Google Scholar
|
3
|
Azzoli CG, Temin S, Aliff T, Baker S,
Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L,
et al: 2011 focused update of 2009 American Society of Clinical
Oncology Clinical Practice guideline update on chemotherapy for
stage IV non-small-cell lung cancer. J Clin Oncol. 29:3825–3831.
2011. View Article : Google Scholar : PubMed/NCBI
|
4
|
Reck M, Popat S, Reinmuth N, De Ruysscher
D, Kerr KM and Peters S; ESMO Guidelines Working Group. Metastatic
non-small-cell lung cancer (NSCLC): ESMO Clinical Practice
Guidelines for diagnosis, treatment and follow-up. Ann Oncol.
25(suppl 3): iii27–iii39. 2014. View Article : Google Scholar : PubMed/NCBI
|
5
|
NCCN. NCCN Clinical Practice Guidelines in
Oncology. Non-small cell lung cancer, V.5. 2015. National
Comprehensive Cancer Network; 2015, http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
Accessed March 19, 2015
|
6
|
Oken MM, Creech RH, Tormey DC, Horton J,
Davis TE, McFadden ET and Carbone PP: Toxicity and response
criteria of the Eastern Cooperative Oncology Group. Am J Clin
Oncol. 5:649–655. 1982. View Article : Google Scholar : PubMed/NCBI
|
7
|
Schag CC, Heinrich RL and Ganz PA:
Karnofsky performance status revisited: Reliability, validity, and
guidelines. J Clin Oncol. 2:187–193. 1984.PubMed/NCBI
|
8
|
Buccheri G, Ferrigno D and Tamburini M:
Karnofsky and ECOG performance status scoring in lung cancer: A
prospective, longitudinal study of 536 patients from a single
institution. Eur J Cancer. 32A:1135–1141. 1996. View Article : Google Scholar : PubMed/NCBI
|
9
|
Kelly K: Challenges in defining and
identifying patients with non-small cell lung cancer and poor
performance status. Semin Oncol. 31(suppl 11): 3–7. 2004.
View Article : Google Scholar : PubMed/NCBI
|
10
|
Radzikowska E, Glaz P and Roszkowski K:
Lung cancer in women: Age, smoking, histology, performance status,
stage, initial treatment and survival. Population based study of 20
561 cases. Ann Oncol. 13:1087–1093. 2002. View Article : Google Scholar : PubMed/NCBI
|
11
|
Lilenbaum RC, Cashy J, Hensing TA, Young S
and Cella D: Prevalence of poor performance status in lung cancer
patients: Implications for research. J Thorac Oncol. 3:125–129.
2008. View Article : Google Scholar : PubMed/NCBI
|
12
|
Albain KS, Crowley JJ, LeBlanc M and
Livingston RB: Survival determinants in extensive-stage
non-small-cell lung cancer: The Southwest Oncology Group
experience. J Clin Oncol. 9:1618–1626. 1991.PubMed/NCBI
|
13
|
Ando M, Ando Y, Sugiura S, Minami H, Saka
H, Sakai S, Shimokata K and Hasegawa Y: Prognostic factors for
short-term survival in patients with stage IV non-small cell lung
cancer. Jpn J Cancer Res. 90:249–253. 1999. View Article : Google Scholar : PubMed/NCBI
|
14
|
Brundage MD, Davies D and Mackillop WJ:
Prognostic factors in non-small cell lung cancer: A decade of
progress. Chest. 122:1037–1057. 2002. View Article : Google Scholar : PubMed/NCBI
|
15
|
Stanley KE: Prognostic factors for
survival in patients with inoperable lung cancer. J Natl Cancer
Inst. 65:25–32. 1980.PubMed/NCBI
|
16
|
Takigawa N, Segawa Y, Okahara M, Maeda Y,
Takata I, Kataoka M and Fujii M: Prognostic factors for patients
with advanced non-small cell lung cancer: Univariate and
multivariate analyses including recursive partitioning and
amalgamation. Lung Cancer. 15:67–77. 1996. View Article : Google Scholar : PubMed/NCBI
|
17
|
Langer C and Lilenbaum R: Role of
chemotherapy in patients with poor performance status and advanced
non-small cell lung cancer. Semin Oncol. 31(suppl 11): 8–15. 2004.
View Article : Google Scholar : PubMed/NCBI
|
18
|
Lee L, Cheung WY, Atkinson E and
Krzyzanowska MK: Impact of comorbidity on chemotherapy use and
outcomes in solid tumors: A systematic review. J Clin Oncol.
29:106–117. 2011. View Article : Google Scholar
|
19
|
Zukin M, Barrios CH, Pereira JR, Ribeiro
Rde A, Beato CA, do Nascimento YN, Murad A, Franke FA, Precivale M,
Araujo LH, et al: Randomized phase III trial of single-agent
pemetrexed versus carboplatin and pemetrexed in patients with
advanced non-small-cell lung cancer and Eastern Cooperative
Oncology Group Performance Status of 2. J Clin Oncol. 31:2849–2853.
2013. View Article : Google Scholar : PubMed/NCBI
|
20
|
Lilenbaum R, Axelrod R, Thomas S, Dowlati
A, Seigel L, Albert D, Witt K and Botkin D: Randomized phase II
trial of erlotinib or standard chemotherapy in patients with
advanced non-small-cell lung cancer and a performance status of 2.
J Clin Oncol. 26:863–869. 2008. View Article : Google Scholar : PubMed/NCBI
|
21
|
Lilenbaum RC, Herndon JE, List MA, Desch
C, Watson DM, Miller AA, Graziano SL, Perry MC, Saville W,
Chahinian P, et al: Single-agent versus combination chemotherapy in
advanced non-small-cell lung cancer: The Cancer and Leukemia Group
B (study 9730). J Clin Oncol. 23:190–196. 2005. View Article : Google Scholar
|
22
|
Reynolds C, Obasaju C, Schell MJ, Li X,
Zheng Z, Boulware D, Caton JR, DeMarco LC, O'Rourke MA, Shaw Wright
G, et al: Randomized phase III trial of gemcitabine-based
chemotherapy with in situ RRM1 and ERCC1 protein levels for
response prediction in non-small-cell lung cancer. J Clin Oncol.
27:5808–5815. 2009. View Article : Google Scholar : PubMed/NCBI
|
23
|
Morabito A, Gebbia V, Di Maio M, Cinieri
S, Viganò MG, Bianco R, Barbera S, Cavanna L, De Marinis F,
Montesarchio V, et al: Randomized phase III trial of gemcitabine
and cisplatin vs. gemcitabine alone in patients with advanced
non-small cell lung cancer and a performance status of 2: The
CAPPA-2 study. Lung Cancer. 81:77–83. 2013. View Article : Google Scholar : PubMed/NCBI
|
24
|
Lilenbaum R, Villaflor VM, Langer C,
O'Byrne K, O'Brien M, Ross HJ, Socinski M, Oldham FB, Sandilac L,
Singer JW, et al: Single-agent versus combination chemotherapy in
patients with advanced non-small cell lung cancer and a performance
status of 2: Prognostic factors and treatment selection based on
two large randomized clinical trials. J Thorac Oncol. 4:869–874.
2009. View Article : Google Scholar : PubMed/NCBI
|
25
|
Shih C, Habeck LL, Mendelsohn LG, Chen VJ
and Schultz RM: Multiple folate enzyme inhibition: Mechanism of a
novel pyrrolopyrimidine-based antifolate LY231514 (MTA). Adv Enzyme
Regul. 38:135–152. 1998. View Article : Google Scholar : PubMed/NCBI
|
26
|
Alimta [package insert]. Indianapolis, IN:
Eli Lilly and Company; 2013
|
27
|
Ciuleanu T, Brodowicz T, Zielinski C, Kim
JH, Krzakowski M, Laack E, Wu Y-L, Bover I, Begbie S, Tzekova V, et
al: Maintenance pemetrexed plus best supportive care versus placebo
plus best supportive care for non-small-cell lung cancer: A
randomised, double-blind, phase 3 study. Lancet. 374:1432–1440.
2009. View Article : Google Scholar : PubMed/NCBI
|
28
|
Hanna N, Shepherd FA, Fossella FV, Pereira
JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TCY, Pless M,
Muller T, et al: Randomized phase III trial of pemetrexed versus
docetaxel in patients with non-small-cell lung cancer previously
treated with chemotherapy. J Clin Oncol. 22:1589–1597. 2004.
View Article : Google Scholar : PubMed/NCBI
|
29
|
Paz-Ares L, de Marinis F, Dediu M, Thomas
M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, et
al: Maintenance therapy with pemetrexed plus best supportive care
versus placebo plus best supportive care after induction therapy
with pemetrexed plus cisplatin for advanced non-squamous
non-small-cell lung cancer (PARAMOUNT): A double-blind, phase 3,
randomised controlled trial. Lancet Oncol. 13:247–255. 2012.
View Article : Google Scholar : PubMed/NCBI
|
30
|
Paz-Ares LG, de Marinis F, Dediu M, Thomas
M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, et
al: PARAMOUNT: Final overall survival results of the phase III
study of maintenance pemetrexed versus placebo immediately after
induction treatment with pemetrexed plus cisplatin for advanced
nonsquamous non-small-cell lung cancer. J Clin Oncol. 31:2895–2902.
2013. View Article : Google Scholar : PubMed/NCBI
|
31
|
Scagliotti GV, Parikh P, von Pawel J,
Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U,
Digumarti R, Zukin M, et al: Phase III study comparing cisplatin
plus gemcitabine with cisplatin plus pemetrexed in
chemotherapy-naive patients with advanced-stage non-small-cell lung
cancer. J Clin Oncol. 26:3543–3551. 2008. View Article : Google Scholar : PubMed/NCBI
|
32
|
European Medicines Agency (EMEA).
Committee for Medicinal Products for Human Use (CHMP). Alimta.
EMEA/H/C/000564. 2011, http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000564/human_med_000638.jsp&mid=WC0b01ac058001d124.
Accessed March 19, 2015
|
33
|
Vogelzang NJ, Rusthoven JJ, Symanowski J,
Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S,
Manegold C, et al: Phase III study of pemetrexed in combination
with cisplatin versus cisplatin alone in patients with malignant
pleural mesothelioma. J Clin Oncol. 21:2636–2644. 2003. View Article : Google Scholar : PubMed/NCBI
|
34
|
Clinicaltrials.gov. [Web site]. Available
at: https://www.clinicaltrials.gov/.
Accessed: March 19, 2015
|
35
|
Clinicaltrialsregister.eu. [Web site].
Available at: https://www.clinicaltrialsregister.eu/.
Accessed: March 19, 2015
|
36
|
Clarke SJ, Abratt R, Goedhals L, Boyer MJ,
Millward MJ and Ackland SP: Phase II trial of pemetrexed disodium
(ALIMTA, LY231514) in chemotherapy-naive patients with advanced
non-small-cell lung cancer. Ann Oncol. 13:737–741. 2002. View Article : Google Scholar : PubMed/NCBI
|
37
|
Gridelli C, Kaukel E, Gregorc V,
Migliorino MR, Müller TR, Manegold C, Favaretto A, Martoni A, Caffo
O, Schmittel A, et al: Single-agent pemetrexed or sequential
pemetrexed/gemcitabine as front-line treatment of advanced
non-small cell lung cancer in elderly patients or patients
ineligible for platinum-based chemotherapy: A multicenter,
randomized, phase II trial. J Thorac Oncol. 2:221–229. 2007.
View Article : Google Scholar : PubMed/NCBI
|
38
|
Fudan University. A study of PC sequential
pemetrexed single drug maintenance treatment for NSCLC and related
predictive biomarkers. ClinicalTrials.gov [Internet]. https://www.clinicaltrials.gov/ct2/results?term=NCT01860508. Accessed March 19, 2015
|
39
|
M.D. Anderson Cancer Center and Eli Lilly
and Company. Single agent Alimta in poor performance status in
non-small cell lung cancer. ClinicalTrials.gov [Internet].
http://www.clinicaltrials.gov/ct2/results?term=NCT00508144
NLM Identifier NCT00508144. Accessed March 19, 2015
|
40
|
Blakely LJ, Schwartzberg L, Keaton M,
Schnell F, Henry D, Epperson A and Walker MS: A phase II trial of
pemetrexed and gemcitabine as first line therapy for poor
performance status and/or elderly patients with stage IIIB/IV
non-small cell lung cancer. Lung Cancer. 66:97–102. 2009.
View Article : Google Scholar : PubMed/NCBI
|
41
|
Grønberg BH, Bremnes RM, Fløtten O,
Amundsen T, Brunsvig PF, Hjelde HH, Kaasa S, von Plessen C, Stornes
F, Tollali T, et al: Phase III study by the Norwegian lung cancer
study group: Pemetrexed plus carboplatin compared with gemcitabine
plus carboplatin as first-line chemotherapy in advanced non small
cell lung cancer. J Clin Oncol. 27:3217–3224. 2009. View Article : Google Scholar
|
42
|
Lilenbaum R, Hainsworth J, Joseph M,
Shipley D, Hagan K, Thompson D, Greco F, Burris H and Spigel D:
Randomized phase II study of pemetrexed v. pemetrexed/bevacizumab
v. carboplatin/pemetrexed/bevacizumab in patients with previously
untreated advanced non-squamous non-small-cell lung cancer and poor
performance status. J Thorac Oncol. 8(Suppl 2): S889–S890.
2013.
|
43
|
Schuette W, Nagel S, Schneider CP,
Engel-Riedel W, Schumann C, Kohlhaeufl M, Serke M, Hoeffken G,
Kortsik C, Reck M, et al: 65 plus: A randomized phase III trial of
pemetrexed and bevacizumab versus pemetrexed, bevacizumab, and
carboplatin as first-line treatment for elderly patients with
advanced nonsquamous, non-small cell lung cancer (NSCLC). ASCO
Annual Meeting. J Clin Oncol. 31:abs 8013. 2013.
|
44
|
Shepherd FA, Dancey J, Ramlau R, Mattson
K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R,
et al: Prospective randomized trial of docetaxel versus best
supportive care in patients with non-small-cell lung cancer
previously treated with platinum-based chemotherapy. J Clin Oncol.
18:2095–2103. 2000.PubMed/NCBI
|
45
|
Fossella FV, DeVore R, Kerr RN, Crawford
J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, et al:
Randomized phase III trial of docetaxel versus vinorelbine or
ifosfamide in patients with advanced non-small-cell lung cancer
previously treated with platinum-containing chemotherapy regimens.
The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol.
18:2354–2362. 2000.PubMed/NCBI
|
46
|
Scagliotti G, Hanna N, Fossella F,
Sugarman K, Blatter J, Peterson P, Simms L and Shepherd FA: The
differential efficacy of pemetrexed according to NSCLC histology: A
review of two Phase III studies. Oncologist. 14:253–263. 2009.
View Article : Google Scholar : PubMed/NCBI
|
47
|
Scagliotti G, Brodowicz T, Shepherd FA,
Zielinski C, Vansteenkiste J, Manegold C, Simms L, Fossella F,
Sugarman K and Belani CP: Treatment-by-histology interaction
analyses in three phase III trials show superiority of pemetrexed
in nonsquamous non-small cell lung cancer. J Thorac Oncol. 6:64–70.
2011.
|
48
|
Ruckdeschel JC, Finkelstein DM, Ettinger
DS, Creech RH, Mason BA, Joss RA and Vogl S: A randomized trial of
the four most active regimens for metastatic non-small-cell lung
cancer. J Clin Oncol. 4:14–22. 1986.PubMed/NCBI
|
49
|
Schiller JH, Harrington D, Belani CP,
Langer C, Sandler A, Krook J, Zhu J and Johnson DH; Eastern
Cooperative Oncology Group. Comparison of four chemotherapy
regimens for advanced non-small-cell lung cancer. N Engl J Med.
346:92–98. 2002. View Article : Google Scholar : PubMed/NCBI
|
50
|
Sweeney CJ, Zhu J, Sandler AB, Schiller J,
Belani CP, Langer C, Krook J, Harrington D and Johnson DH: Outcome
of patients with a performance status of 2 in Eastern Cooperative
Oncology Group Study E1594: A Phase II trial in patients with
metastatic non-small cell lung carcinoma. Cancer. 92:2639–2647.
2001. View Article : Google Scholar : PubMed/NCBI
|
51
|
Ando M, Ando Y, Hasegawa Y, Shimokata K,
Minami H, Wakai K, Ohno Y and Sakai S: Prognostic value of
performance status assessed by patients themselves, nurses, and
oncologists in advanced non-small cell lung cancer. Br J Cancer.
85:1634–1639. 2001. View Article : Google Scholar : PubMed/NCBI
|
52
|
Blagden SP, Charman SC, Sharples LD, Magee
LR and Gilligan D: Performance status score: Do patients and their
oncologists agree? Br J Cancer. 89:1022–1027. 2003. View Article : Google Scholar : PubMed/NCBI
|
53
|
Morère JF, Bréchot JM, Westeel V, Gounant
V, Lebeau B, Vaylet F, Barlési F, Urban T, Souquet P-J, Debieuvre
D, et al: Randomized phase II trial of gefitinib or gemcitabine or
docetaxel chemotherapy in patients with advanced non-small-cell
lung cancer and a performance status of 2 or 3 (IFCT-0301 study).
Lung Cancer. 70:301–307. 2010. View Article : Google Scholar : PubMed/NCBI
|
54
|
Charlson ME, Pompei P, Ales KL and
MacKenzie CR: A new method of classifying prognostic comorbidity in
longitudinal studies: Development and validation. J Chronic Dis.
40:373–383. 1987. View Article : Google Scholar : PubMed/NCBI
|
55
|
Langer C, Li S, Schiller J, Tester W,
Rapoport BL and Johnson DH; Eastern Cooperative Oncology Group.
Randomized phase II trial of paclitaxel plus carboplatin or
gemcitabine plus cisplatin in Eastern Cooperative Oncology Group
performance status 2 non-small-cell lung cancer patients: ECOG
1599. J Clin Oncol. 25:418–423. 2007. View Article : Google Scholar : PubMed/NCBI
|
56
|
D'Addario G, Früh M, Reck M, Baumann P,
Klepetko W and Felip E; ESMO Guidelines Working Group. Metastatic
non small-cell lung cancer: ESMO Clinical Practice Guidelines for
diagnosis, treatment and follow-up. Ann Oncol. 21(suppl 5):
v116–v119. 2010. View Article : Google Scholar
|
57
|
Perrone F, Di Maio M, Gallo C and Gridelli
C: Outcome of patients with a performance status of 2 in the
Multicenter Italian Lung Cancer in the Elderly Study (MILES). J
Clin Oncol. 22:5018–5020. 2004. View Article : Google Scholar : PubMed/NCBI
|
58
|
Soria JC, Brisgand D and Le Chevalier T:
Do all patients with advanced non small cell lung cancer benefit
from cisplatin-based combination therapy? Ann Oncol. 12:1667–1670.
2001. View Article : Google Scholar
|
59
|
Patel JD, Socinski MA, Garon EB, Reynolds
CH, Spigel DR, Olsen MR, Hermann RC, Jotte RM, Beck T, Richards DA,
et al: PointBreak: A randomized phase III study of pemetrexed plus
carboplatin and bevacizumab followed by maintenance pemetrexed and
bevacizumab versus paclitaxel plus carboplatin and bevacizumab
followed by maintenance bevacizumab in patients with stage IIIB or
IV nonsquamous non-small-cell lung cancer. J Clin Oncol.
31:4349–4357. 2013. View Article : Google Scholar : PubMed/NCBI
|
60
|
Brodowicz T, Krzakowski M, Zwitter M,
Tzekova V, Ramlau R, Ghilezan N, Ciuleanu T, Cucevic B, Gyurkovits
K, Ulsperger E, et al; for the Central European Cooperative
Oncology Group. Cisplatin and gemcitabine first-line chemotherapy
followed by maintenance gemcitabine or best supportive care in
advanced non-small cell lung cancer: A phase III trial. Lung
Cancer. 52:155–163. 2006. View Article : Google Scholar : PubMed/NCBI
|
61
|
Belani CP, Waterhouse DM, Ghazal H,
Ramalingam SS, Bordoni R, Greenberg R, Levine RM, Waples JM, Jiang
Y and Reznikoff G: Phase III study of maintenance gemcitabine (G)
and best supportive care (BSC) versus BSC, following standard
combination therapy with gemcitabine carboplatin (G-Cb) for
patients with advanced non-small cell lung cancer (NSCLC). ASCO
Annual Meeting. J Clin Oncol. 28:abs 7506. 2010.
|
62
|
Paz-Ares L, Zimmermann A, Ciuleanu T-E,
Bunn PA, San Antonio B, Denne J, Iturria N, John WJ and Scagliotti
GV: Meta-analysis examining impact of age on pemetrexed (pem)
efficacy for the treatment of advanced nonsquamous (NS) non-small
cell lung cancer (NSCLC). J Clin Oncol. 32:abs e19040. 2014.
|
63
|
Gridelli C, de Marinis F, Thomas M,
Prabhash K, El Kouri C, Blackhall F, Bustin F, Pujol JL, John WJ,
San Antonio B, et al: Final efficacy and safety results of
pemetrexed continuation maintenance therapy in the elderly from the
PARAMOUNT phase III study. J Thorac Oncol. 9:991–997. 2014.
View Article : Google Scholar : PubMed/NCBI
|