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Table 4 Summary of key findings from main phase III randomized controlled trials administrating immunotherapy on the elderly

From: Aging microenvironment and antitumor immunity for geriatric oncology: the landscape and future implications

Trial name

Year

Intervention and control settings

Participants’ characteristics

Key results and findings

Malignant melanoma

dacarbazine + ipilimumab versus dacarbazine + placebo (NCT00324155) [338]

2011

First line dacarbazine + ipilimumab versus dacarbazine

N = 502; median age = 57 yr; 65 years: 32%

OS ≥ 65 yr, HR: 0.99 (0.56–1.25); OS < 65 yr, HR: 0.67 (0.40–0.87)

KEYNOTE-006 (NCT01866319) [339]

2015

First line or pretreated pembrolizumab versus ipilimumab

N = 834; median age = 62 yr; 65 years: 43%

OS ≥ 65 yr, HR: 0.56 (0.36–0.87); OS < 65 yr, HR: 0.65 (0.44–0.95)

CheckMate 066 (NCT01721772) [340]

2014

First line nivolumab versus dacarbazine

N = 418; median age = 65 yr; 65 years: 52%

OS ≥ 75 yr, HR: 0.25 (0.10–0.61); OS 65–74 yr, HR: 0.44 (0.24–0.81); OS < 65 yr, HR: 0.52 (0.32–0.85)

CheckMate 067 (NCT01844505) [341]

2017

First line nivolumab + ipilimumab versus ipilimumab versus nivolumab

N = 945; median age = 60 yr; 65 years: 40%

OS ≥ 65 yr, HR: 0.69; OS < 65 yr, HR: 0.48 (n + i vs. i); OS ≥ 65 yr, HR: 0.96; OS < 65 yr, HR: 0.78 (n + i vs. n); OS ≥ 65 yr, HR: 0.71; OS < 65 yr, HR: 0.62 (n vs. i)

CheckMate 238 (NCT02388906) [342]

2017

Adjuvant nivolumab versus ipilimumab

N = 906; median age = 55 yr; 65 years: 26%

RFS ≥ 65 yr, HR: 0.66 (0.45–0.97); RFS < 65 yr, HR: 0.65 (0.51–0.84)

KEYNOTE-054 (NCT02362594) [343]

2018

Adjuvant pembrolizumab versus placebo

N = 1019; median age = 54 yr; 65 years: 25%

RFS ≥ 65 yr, HR: 0.55 (0.32–0.93); RFS < 65 yr, HR: 0.57 (0.41–0.80)

Non-small cell lung cancer

KEYNOTE-024 (NCT02142738) [344]

2016

First line, TPS > 50%, pembrolizumab versus platinum-based chemotherapy

N = 305; median age = 65 yr; 65 years: 54%

OS ≥ 65 yr, HR: 0.64 (0.42–0.98); OS < 65 yr, HR: 0.60 (0.38–0.96)

KEYNOTE-042 (NCT02220894) [345]

2019

First line, TPS > 1%, pembrolizumab versus platinum-based chemotherapy

N = 1274; median age = 63 yr; 65 years: 45%

OS ≥ 65 yr, HR: 0.82 (0.66–1.01); OS < 65 yr, HR: 0.81 (0.67–0.98)

KEYNOTE-010 (NCT01905657) [346]

2016

Pretreated, pembrolizumab versus docetaxel

N = 1034; median age = 63 yr; 65 years: 41%

OS ≥ 65 yr, HR: 0.76 (0.57–1.02); OS < 65 yr, HR: 0.63 (0.50–0.79)

CheckMate 017 (NCT01642004) [347]

2015

Pretreated squamous, nivolumab versus docetaxel

N = 272; median age = 63 yr; 65 years: 44%

OS ≥ 75 yr, HR: 1.85 (0.76–4.51); OS 65–74 yr, HR: 0.56 (0.34–0.91); OS < 65 yr, HR: 0.52 (0.35–0.75)

CheckMate 057 (NCT01673867) [348]

2015

Pretreated non squamous, nivolumab versus docetaxel

N = 582; median age = 62 yr; 65 years: 42%

OS ≥ 75 yr, HR: 0.90 (0.43–0.87); OS 65–74 yr, HR: 0.63 (0.45–0.89); OS < 65 yr, HR: 0.81 (0.62–1.04)

OAK (NCT02008227) [349]

2017

Pretreated, atezolizumab versus docetaxel

N = 850; median age = 64 yr; 65 years: 47%

OS ≥ 65 yr, HR: 0.66 (0.52–0.83); OS < 65 yr, HR: 0.80 (0.64–1.00)

PACIFIC (NCT02125461) [350]

2017

Adjuvant concurrent chemoradiotherapy followed by durvalumab versus placebo

N = 709; median age = 64 yr; 65 years: 45%

OS ≥ 65 yr, HR: 0.76 (0.55–1.06); OS < 65 yr, HR: 0.62 (0.44–0.86)

KEYNOTE-189 (NCT02578680) [351]

2018

First line non squamous, cisplatin or carboplatin + pemetrexed + pembrolizumab versus cisplatin or carboplatin + pemetrexed

N = 616; median age = 64 yr; 65 years: 49%

OS ≥ 65 yr, HR: 0.64 (0.43–0.95); OS < 65 yr, HR: 0.43 (0.31–0.61)

KEYNOTE-407 (NCT02775435) [352]

2018

First line squamous, carboplatin + paclitaxel + pembrolizumab

N = 559; median age = 65 yr; 65 years: 55%

OS ≥ 65 yr, HR: 0.74 (0.51–1.07); OS < 65 yr, HR: 0.52 (0.34–0.80)

CheckMate 227 (NCT02477826) [353]

2019

First line, TPS > 1%, nivolumab + ipilimumab versus platinum-based chemotherapy

N = 1189; median age = 64 yr; 65 years: 49%

OS ≥ 75 yr, HR: 0.92 (0.57–1.48); OS 65–74 yr, HR: 0.91 (0.70–1.19); OS < 65 yr, HR: 0.70 (0.55–0.89)

CheckMate 9LA (NCT03215706) [354]

2021

First line nivolumab + ipilimumab + platinum-based chemotherapy versus platinum-based chemotherapy

N = 719; median age = 65 yr; 65 years: 51%

OS ≥ 75 yr, HR: 1.21; OS 65–74 yr, HR: 0.62; OS < 65 yr, HR: 0.61

IMpower150 (NCT02366143) [355]

2018

First line or post-TKI non squamous carboplatin + paclitaxel + bevacizumab + atezolizumab versus carboplatin + paclitaxel + bevacizumab

N = 800; median age = 63 yr; 65 years: 45%

PFS ≥ 75 yr, HR: 0.78; PFS 65–74 yr, HR: 0.52; PFS < 65 yr, HR: 0.65

IMpower010 (NCT02486718) [356]

2021

resected IB-IIIA with chemotherapy followed by atezolizumab versus BSC

N = 1005; median age = 62 yr; 65 years: 67%

DFS ≥ 65 yr, HR: 0.76 (0.54–1.05); DFS < 65 yr, HR: 0.79 (0.61–1.03)

Renal cell carcinoma

CheckMate 025 (NCT01668784) [357]

2015

Pretreated nivolumab versus everolimus

N = 821; median age = 62 yr; 65 years: 39%

OS ≥ 75 yr, HR: 1.23 (0.66–2.31); OS 65–74 yr, HR: 0.64 (0.45–0.91); OS < 65 yr, HR: 0.78 (0.60–1.01)

CheckMate 214 (NCT02231749) [358]

2018

First line nivolumab + ipilimumab versus sunitinib

N = 1096; median age = 62 yr; 65 years: 38%

OS ≥ 75 yr, HR: 0.97 (0.48–1.95); OS 65–74 yr, HR: 0.86 (0.58–1.27); OS < 65 yr, HR: 0.53 (0.40–0.71)

KEYNOTE-426 (NCT02853331) [359]

2019

First line pembrolizumab + axitinib versus sunitinib

N = 861; median age = 62 yr; 65 years: 38%

OS ≥ 65 yr, HR: 0.59 (0.36–0.97); OS < 65 yr, HR: 0.47 (0.30–0.73)

JAVELIN 101 (NCT02684006) [360]

2019

First line avelumab + axitinib versus sunitinib

N = 886; median age = 61 yr; 65 years: 38%

PFS ≥ 65 yr, HR: 0.70 (0.49–0.99); PFS < 65 yr, HR: 0.68 (0.54–0.87)

Urothelial carcinoma

KEYNOTE-045 (NCT02256436) [361]

2017

Pretreated pembrolizumab versus investigator choice chemotherapy

N = 542; median age = 66 yr; 65 years: 58%

OS ≥ 65 yr, HR: 0.76 (0.56–1.02); OS < 65 yr, HR: 0.75 (0.53–1.05)

IMvigor-130 (NCT02807636) [362]

2020

First line platinum-based chemotherapy + atezolizumab versus platinum-based chemotherapy

N = 1231; median age = 68 yr; 65 years: 63%

PFS ≥ 65 yr, HR: 0.80 (0.66–0.97); PFS < 65 yr, HR: 0.82 (0.63–1.06)

JAVELIN 100 (NCT02603432) [363]

2020

first line maintenance avelumab + BSC versus BSC

N = 700; median age = 69 yr; 65 years: 66%

OS ≥ 65 yr, HR: 0.63 (0.47–0.83); OS < 65 yr, HR: 0.79 (0.55–1.15)

  1. OS overall survival, HR hazard ratio, RFS recurrence-free survival, PFS progression-free survival, DFS disease-free survival, TPS tumor proportion score, TKI tyrosine kinase inhibitor, BSC best supportive care, yr year (Mainly from https://doi.org/10.1200/JCO.21.00138)