246 Effectiveness and utilization of first-line immune checkpoint inhibitors for patients with extracranial & intracranial metastatic melanoma Article Swipe

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YOU? · · 2021 · Open Access · · DOI: https://doi.org/10.1136/jitc-2021-sitc2021.246

Background We previously demonstrated the effectiveness of 2nd-line immune checkpoint inhibitors (ICI) for stage 4 melanoma patients.^{1 2}In late 2015, ICI was FDA-approved and NCCN-recommended in the 1st-line setting.^{3 4} Here we assess the real-world effectiveness and utilization of 1st-line ICI among advanced melanoma patients following 2015. Methods Patients newly-diagnosed with stage 4 melanoma during 2010–2018 were identified using the U.S. National Cancer Database (comprises >70% of newly-diagnosed cancers).⁵ Post-approval 1st-line ICI's overall survival (OS, estimated by Kaplan-Meier techniques) and utilization were assessed for patients diagnosed in 2016–2018, using multivariable Cox and logistic regression, respectively. To account for immortal time bias in receiving ICI, we only included those patients in regression analyses who survived at least until the landmark timepoint, defined as the median time from diagnosis to ICI initiation (49 days).^{1 2} The more conservative 75th percentile diagnosis-to-ICI-initiation landmark timepoint (80 days) was also evaluated. Analyses were adjusted for patient, tumor, treatment, socioeconomic, and care setting characteristics. Results Among 14,912 stage 4 melanoma patients, 1st-line immunotherapy utilization increased from 8.4% in 2010 to 39.2% in 2015, and 57.9% in 2018.(Figure 1) Altogether, median OS improved from 8.0 mos (95%CI=7.3–8.8) in 2010 to 16.1 mos (95%CI=14.0–18.5) in 2017. For patients diagnosed in 2016+ who survived at least until the landmark timepoints, OS improved with 1st-line ICI (median OS=33.1 mos, 95%CI=29.4–40.5; vs just 13.6 mos for no ICI, 95%CI=12.1–16.1; HR=0.58, 99%CI=0.50–0.68; padj<0.001)(figure 2A-B)—even after adjusting for patient, disease, and treatment factors, and using either landmark.(Table 1) This included patients with either brain metastases (ICI median OS=16.7 mos, 95%CI=13.1–19.9; vs no ICI=7.8 mos, 95%CI=6.8–9.0; padj<0.001) or lung metastases (ICI median OS=26.0 mos, 95%CI=20.0–33.0; vs no ICI=9.3 mos, 95%CI=8.0–10.5; padj<0.001).(Figure 2C-F)We then used multivariable logistic regression (with landmark timepoints to reduce bias from early mortality) to identify putative barriers to receiving 1st-line ICI in 2016+. Advanced melanoma patients who had more comorbidities or brain metastases, or who were older, uninsured/Medicaid-insured, from the poorest quartile of households, or managed at community hospitals were less likely to receive ICI.(all p<0.05, table 2) Conclusions Following FDA-approval in 2015, 1st-line ICI was associated with dramatic improvements in OS for stage 4 melanoma patients—including those with brain or lung metastases. As of 2018, 42% of patients still weren't receiving 1st-line ICI in the U.S.—particularly patients who were underinsured, from the poorest quartile of households, or managed at community hospitals—suggesting that disparities exist in guideline-recommended 1st-line ICI utilization for advanced melanoma patients. References Dobry A, Zogg C, Hodi F, Smith T, Ott P, Iorgulescu JB. Management of metastatic melanoma: improved survival in a national cohort following the approvals of checkpoint blockade immunotherapies and targeted therapies. Cancer Immunol Immunother 2018 December;67(12):1833–1844. Iorgulescu JB, Harary M, Zogg C, Ligon K, Reardon D, Hodi F, Aizer A, Smith T. Improved risk-adjusted survival for melanoma brain metastases in the era of checkpoint blockade immunotherapies: results from a national cohort. Cancer Immunol Res 2018 September;6(9):1039–1045. Beaver JA, Theoret MR, Mushti S, He K, Libeg M, Goldberg K, Sridhara R, McKee AE, Keegan P, Pazdur R. FDA approval of nivolumab for the first-line treatment of patients with BRAFV600 wild-type unresectable or metastatic melanoma. Clin Cancer Res 2017 July 15;23(14):3479–3483 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Melanoma, Version 1.2016. Boffa DJ, Rosen JE, Mallin K, Loomis A, Gay G, Palis B, Thoburn K, Gress D, McKellar DP, Shulman LN, Facktor MA, Winchester DP. Using the national cancer database for outcomes research: a review. JAMA Oncol 2017 December 1;3(12):1722–1728.

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Medicine Ipilimumab Melanoma Internal medicine Cancer Proportional hazards model Stage (stratigraphy) Oncology Immunotherapy Cancer research Paleontology Biology

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Type: article
Language: en
Landing Page: https://doi.org/10.1136/jitc-2021-sitc2021.246
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DOI: https://doi.org/10.1136/jitc-2021-sitc2021.246

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Title: 246 Effectiveness and utilization of first-line immune checkpoint inhibitors for patients with extracranial & intracranial metastatic melanoma

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Publication year: 2021

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Publication date: 2021-11-01

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Authors: Nayan Lamba, Bryan Iorgulescu

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Concepts: Medicine, Ipilimumab, Melanoma, Internal medicine, Cancer, Proportional hazards model, Stage (stratigraphy), Oncology, Immunotherapy, Cancer research, Paleontology, Biology

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abstract_inverted_index.more	134, 307
abstract_inverted_index.mos,	218, 255, 260, 269, 274
abstract_inverted_index.only	105
abstract_inverted_index.that	391
abstract_inverted_index.then	278
abstract_inverted_index.time	99, 124
abstract_inverted_index.used	279
abstract_inverted_index.were	56, 81, 147, 314, 328, 378
abstract_inverted_index.with	50, 213, 248, 346, 357, 511
abstract_inverted_index.(ICI)	11
abstract_inverted_index.(with	283
abstract_inverted_index.2015,	19, 176, 341
abstract_inverted_index.2015.	46
abstract_inverted_index.2016+	202
abstract_inverted_index.2017.	197
abstract_inverted_index.2018,	364
abstract_inverted_index.39.2%	174
abstract_inverted_index.57.9%	178
abstract_inverted_index.Aizer	453
abstract_inverted_index.Among	159
abstract_inverted_index.Boffa	536
abstract_inverted_index.Dobry	404
abstract_inverted_index.Gress	550
abstract_inverted_index.ICI's	71
abstract_inverted_index.Libeg	489
abstract_inverted_index.Ligon	447
abstract_inverted_index.McKee	495
abstract_inverted_index.Palis	546
abstract_inverted_index.Rosen	538
abstract_inverted_index.Smith	410, 455
abstract_inverted_index.Using	560
abstract_inverted_index.after	232
abstract_inverted_index.among	41
abstract_inverted_index.brain	250, 310, 358, 462
abstract_inverted_index.days)	142
abstract_inverted_index.early	290
abstract_inverted_index.exist	393
abstract_inverted_index.least	115, 206
abstract_inverted_index.stage	13, 51, 161, 352
abstract_inverted_index.still	368
abstract_inverted_index.table	335
abstract_inverted_index.those	107, 356
abstract_inverted_index.until	116, 207
abstract_inverted_index.using	58, 88, 241
abstract_inverted_index.14,912	160
abstract_inverted_index.2016+.	301
abstract_inverted_index.Beaver	481
abstract_inverted_index.Cancer	62, 519, 526
abstract_inverted_index.Harary	443
abstract_inverted_index.Keegan	497
abstract_inverted_index.Loomis	542
abstract_inverted_index.Mallin	540
abstract_inverted_index.Mushti	485
abstract_inverted_index.Pazdur	499
abstract_inverted_index.assess	32
abstract_inverted_index.cancer	563
abstract_inverted_index.cohort	425
abstract_inverted_index.during	54
abstract_inverted_index.either	242, 249
abstract_inverted_index.immune	8
abstract_inverted_index.likely	330
abstract_inverted_index.median	123, 183, 253, 267
abstract_inverted_index.older,	315
abstract_inverted_index.reduce	287
abstract_inverted_index.tumor,	151
abstract_inverted_index.>70%	65
abstract_inverted_index.(median	216
abstract_inverted_index.1.2016.	535
abstract_inverted_index.2</sup>	132
abstract_inverted_index.2C-F)We	277
abstract_inverted_index.4</sup>	29
abstract_inverted_index.<i>JAMA	570
abstract_inverted_index.Facktor	556
abstract_inverted_index.ICI=7.8	259
abstract_inverted_index.ICI=9.3	273
abstract_inverted_index.Immunol	437, 477
abstract_inverted_index.Network	527
abstract_inverted_index.OS=16.7	254
abstract_inverted_index.OS=26.0	268
abstract_inverted_index.OS=33.1	217
abstract_inverted_index.Reardon	449
abstract_inverted_index.Res</i>	478, 520
abstract_inverted_index.Shulman	554
abstract_inverted_index.Theoret	483
abstract_inverted_index.Thoburn	548
abstract_inverted_index.Version	534
abstract_inverted_index.account	96
abstract_inverted_index.cohort.	475
abstract_inverted_index.defined	120
abstract_inverted_index.managed	324, 387
abstract_inverted_index.overall	72
abstract_inverted_index.poorest	319, 382
abstract_inverted_index.receive	332
abstract_inverted_index.results	471
abstract_inverted_index.review.	569
abstract_inverted_index.setting	156
abstract_inverted_index.weren't	369
abstract_inverted_index.1st-line	27, 39, 70, 165, 214, 298, 342, 371, 396
abstract_inverted_index.2nd-line	7
abstract_inverted_index.Advanced	302
abstract_inverted_index.Analyses	146
abstract_inverted_index.BRAFV600	512
abstract_inverted_index.Clinical	528
abstract_inverted_index.Database	63
abstract_inverted_index.December	573
abstract_inverted_index.Goldberg	491
abstract_inverted_index.HR=0.58,	228
abstract_inverted_index.ICI.(all	333
abstract_inverted_index.Improved	457
abstract_inverted_index.McKellar	552
abstract_inverted_index.National	61, 524
abstract_inverted_index.Patients	48
abstract_inverted_index.Practice	529
abstract_inverted_index.Sridhara	493
abstract_inverted_index.adjusted	148
abstract_inverted_index.advanced	42, 400
abstract_inverted_index.analyses	111
abstract_inverted_index.approval	502
abstract_inverted_index.assessed	82
abstract_inverted_index.barriers	295
abstract_inverted_index.blockade	431, 469
abstract_inverted_index.database	564
abstract_inverted_index.disease,	236
abstract_inverted_index.dramatic	347
abstract_inverted_index.factors,	239
abstract_inverted_index.identify	293
abstract_inverted_index.immortal	98
abstract_inverted_index.improved	185, 212, 420
abstract_inverted_index.included	106, 246
abstract_inverted_index.landmark	118, 139, 209, 284
abstract_inverted_index.logistic	92, 281
abstract_inverted_index.melanoma	15, 43, 53, 163, 303, 354, 401, 461
abstract_inverted_index.national	424, 474, 562
abstract_inverted_index.outcomes	566
abstract_inverted_index.patient,	150, 235
abstract_inverted_index.patients	44, 84, 108, 199, 247, 304, 367, 376, 510
abstract_inverted_index.putative	294
abstract_inverted_index.quartile	320, 383
abstract_inverted_index.survival	73, 421, 459
abstract_inverted_index.survived	113, 204
abstract_inverted_index.targeted	434
abstract_inverted_index.2</sup>In	17
abstract_inverted_index.<i>Cancer	436, 476
abstract_inverted_index.Following	338
abstract_inverted_index.Melanoma,	533
abstract_inverted_index.Oncol</i>	571
abstract_inverted_index.Oncology.	532
abstract_inverted_index.adjusting	233
abstract_inverted_index.approvals	428
abstract_inverted_index.community	326, 389
abstract_inverted_index.diagnosed	85, 200
abstract_inverted_index.diagnosis	126
abstract_inverted_index.estimated	75
abstract_inverted_index.following	45, 426
abstract_inverted_index.hospitals	327
abstract_inverted_index.increased	168
abstract_inverted_index.melanoma:	419
abstract_inverted_index.nivolumab	504
abstract_inverted_index.patients,	164
abstract_inverted_index.patients.	402
abstract_inverted_index.receiving	102, 297, 370
abstract_inverted_index.research:	567
abstract_inverted_index.timepoint	140
abstract_inverted_index.treatment	238, 508
abstract_inverted_index.wild-type	513
abstract_inverted_index.(comprises	64
abstract_inverted_index.Guidelines	530
abstract_inverted_index.Iorgulescu	414, 441
abstract_inverted_index.Management	416
abstract_inverted_index.Winchester	558
abstract_inverted_index.associated	345
abstract_inverted_index.checkpoint	9, 430, 468
abstract_inverted_index.evaluated.	145
abstract_inverted_index.first-line	507
abstract_inverted_index.identified	57
abstract_inverted_index.inhibitors	10
abstract_inverted_index.initiation	129
abstract_inverted_index.metastases	251, 265, 463
abstract_inverted_index.metastatic	418, 516
abstract_inverted_index.mortality)	291
abstract_inverted_index.p<0.05,	334
abstract_inverted_index.percentile	137
abstract_inverted_index.previously	2
abstract_inverted_index.real-world	34
abstract_inverted_index.regression	110, 282
abstract_inverted_index.therapies.	435
abstract_inverted_index.timepoint,	119
abstract_inverted_index.timepoints	285
abstract_inverted_index.treatment,	152
abstract_inverted_index.2010–2018	55
abstract_inverted_index.Altogether,	182
abstract_inverted_index.disparities	392
abstract_inverted_index.households,	322, 385
abstract_inverted_index.metastases,	311
abstract_inverted_index.metastases.	361
abstract_inverted_index.regression,	93
abstract_inverted_index.techniques)	78
abstract_inverted_index.timepoints,	210
abstract_inverted_index.utilization	37, 80, 167, 398
abstract_inverted_index.2016–2018,	87
abstract_inverted_index.2018.(Figure	180
abstract_inverted_index.2A-B)—even	231
abstract_inverted_index.FDA-approval	339
abstract_inverted_index.FDA-approved	22
abstract_inverted_index.Kaplan-Meier	77
abstract_inverted_index.conservative	135
abstract_inverted_index.days).<sup>1	131
abstract_inverted_index.demonstrated	3
abstract_inverted_index.improvements	348
abstract_inverted_index.melanoma.<i>	517
abstract_inverted_index.unresectable	514
abstract_inverted_index.Comprehensive	525
abstract_inverted_index.Post-approval	69
abstract_inverted_index.comorbidities	308
abstract_inverted_index.effectiveness	5, 35
abstract_inverted_index.immunotherapy	166
abstract_inverted_index.multivariable	89, 280
abstract_inverted_index.respectively.	94
abstract_inverted_index.risk-adjusted	458
abstract_inverted_index.underinsured,	379
abstract_inverted_index.Immunother</i>	438
abstract_inverted_index.padj<0.001)	262
abstract_inverted_index.setting.<sup>3	28
abstract_inverted_index.socioeconomic,	153
abstract_inverted_index.immunotherapies	432
abstract_inverted_index.landmark.(Table	243
abstract_inverted_index.newly-diagnosed	49, 67
abstract_inverted_index.patients.<sup>1	16
abstract_inverted_index.95%CI=6.8–9.0;	261
abstract_inverted_index.<h3>Methods</h3>	47
abstract_inverted_index.<h3>Results</h3>	158
abstract_inverted_index.NCCN-recommended	24
abstract_inverted_index.characteristics.	157
abstract_inverted_index.immunotherapies:	470
abstract_inverted_index.(95%CI=7.3–8.8)	189
abstract_inverted_index.95%CI=8.0–10.5;	275
abstract_inverted_index.95%CI=12.1–16.1;	227
abstract_inverted_index.95%CI=13.1–19.9;	256
abstract_inverted_index.95%CI=20.0–33.0;	270
abstract_inverted_index.95%CI=29.4–40.5;	219
abstract_inverted_index.99%CI=0.50–0.68;	229
abstract_inverted_index.(95%CI=14.0–18.5)	195
abstract_inverted_index.<h3>Background</h3>	0
abstract_inverted_index.<h3>References</h3>	403
abstract_inverted_index.U.S.—particularly	375
abstract_inverted_index.<h3>Conclusions</h3>	337
abstract_inverted_index.patients—including	355
abstract_inverted_index.cancers).<sup>5</sup>	68
abstract_inverted_index.guideline-recommended	395
abstract_inverted_index.padj<0.001)(figure	230
abstract_inverted_index.hospitals—suggesting	390
abstract_inverted_index.padj<0.001).(Figure	276
abstract_inverted_index.1;<b>3</b>(12):1722–1728.	574
abstract_inverted_index.diagnosis-to-ICI-initiation	138
abstract_inverted_index.uninsured/Medicaid-insured,	316
abstract_inverted_index.15;<b>23</b>(14):3479–3483	523
abstract_inverted_index.September;<b>6</b>(9):1039–1045.	480
abstract_inverted_index.December;<b>67</b>(12):1833–1844.	440
cited_by_percentile_year
countries_distinct_count	1
institutions_distinct_count	2
citation_normalized_percentile.value	0.21421764
citation_normalized_percentile.is_in_top_1_percent	False
citation_normalized_percentile.is_in_top_10_percent	False