396O Health-related quality of life (HRQoL) in patients (pts) treated with pembrolizumab (pembro) vs chemotherapy as first-line treatment in microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC): Phase III KEYNOTE-177 study

Thewis, André; Amonkar, Mayur M.; Norquist, Josephine M.; Shiu, Kai Keen; Kim, T.W.; Jensen, Benny Vittrup; Jensen, Lars Henrik; Punt, Cornelis J.A.; Smith, Denis; García‐Carbonero, Rocío; Sevilla, Isabel; Fouchardiere, C. de la; Rivera, Fernando; Élez, Elena; Díaz, Luis A.; Yoshino, Takayuki; Cutsem, Éric Van; Yang, Ping; Farooqui, Mohammed Z.H.; Le, Dung T.

doi:10.1016/j.annonc.2020.08.507

Cited by 9 publications

(21 citation statements)

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“…In patients with MSI-H/dMMR metastatic colorectal cancer receiving pembrolizumab, clinically meaningful improvements were seen in both of these measures, compared with standard of care [66]. In patients with solid tumors harboring NTRK or ROS1 mutations treated with entrectinib, the overall QoL scores showed no change or a trend toward improvement from baseline [77].…”

Section: Impact Of Precision Oncology On Patients and Their Qolmentioning

confidence: 94%

Precision Oncology: a Clinical and Patient Perspective

Lassen

Makaroff²,

Italiano

et al. 2021

Future Oncol.

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Molecular characterization of tumors has shifted cancer treatment strategies away from nonspecific cytotoxic treatment of histology-specific tumors toward targeting of actionable mutations that can be found across multiple cancer types. The development of high-throughput technologies such as next-generation sequencing, combined with decision support applications and availability of patient databases, has provided tools that optimize disease management. Precision oncology has proven success in improving outcomes and quality of life, as well as identifying and overcoming mechanisms of drug resistance and relapse. Addressing challenges that impede its use will improve matching of therapies to patients. Here we review the current status of precision oncology medicine, emphasizing its impact on patients – what they understand about precision oncology medicine and their hopes for the future.

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Section: Impact Of Precision Oncology On Patients and Their Qolmentioning

confidence: 94%

Precision Oncology: a Clinical and Patient Perspective

Lassen

Makaroff²,

Italiano

et al. 2021

Future Oncol.

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show abstract

“…In MSI-H CRC, the survival and QoL benefits of first-line pembrolizumab monotherapy relative to conventional chemotherapy were demonstrated in the KEYNOTE-177 study [ 9 , 10 ]. The important message here is that MSI-H CRC should be treated differently from MSS CRC, and we hypothesized that this distinction may also be applicable to other tumor types.…”

Section: Discussionmentioning

confidence: 99%

“…Among such tumors, colorectal cancer (CRC) has been studied most closely. The KEYNOTE-177 study recently showed that pembrolizumab monotherapy in the first-line setting conferred a superior progression-free survival (PFS) [ 9 ] as well as a better QoL [ 10 ] compared with chemotherapy for patients with MSI-H CRC ( Table 1 ), resulting in pembrolizumab monotherapy becoming the standard first-line treatment for such patients in the United States. The KEYNOTE-062 phase 3 study evaluated pembrolizumab with or without chemotherapy versus chemotherapy alone in the first-line setting for GC, demonstrating noninferiority of pembrolizumab monotherapy relative to chemotherapy in patients with a programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) of ≥1 [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

An Investigator-Initiated Phase 2 Study of Nivolumab Plus Low-Dose Ipilimumab as First-Line Therapy for Microsatellite Instability—High Advanced Gastric or Esophagogastric Junction Cancer (NO LIMIT, WJOG13320G/CA209-7W7)

Kawakami

Hironaka

Esaki

et al. 2021

Cancers

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Nivolumab (NIVO) plus low-dose ipilimumab (IPI) has shown a promising survival benefit in first-line treatment of microsatellite instability-high (MSI-H) colorectal cancer. We hypothesized that this regimen might also be beneficial for MSI-H gastric cancer (GC), which accounts for ~5% of all GC cases. NO LIMIT (WJOG13320G/CA209-7W7) is an investigator-initiated, single-arm, open-label, 14-center phase 2 trial of NIVO plus low-dose IPI for MSI-H GC in the first-line setting. Eligibility criteria include unresectable advanced, recurrent, or metastatic gastric or esophagogastric junction cancer with a histologically confirmed diagnosis of adenocarcinoma; confirmed MSI-H status with the MSI-IVD Kit (FALCO); no prior systemic anticancer therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and a measurable lesion per RECIST 1.1. The primary objective of the study is to determine the overall response rate (ORR) for the NIVO+IPI regimen as assessed by blinded independent central review. Secondary end points include progression-free survival, overall survival, duration of response, safety, tolerability, and biomarkers. The number of patients was set at 28 on the basis of the threshold and expected ORR values of 35 and 65%, respectively, with a one-sided alpha error of 0.025 and power of 0.80. Subjects will receive treatment with nivolumab (240 mg) biweekly in combination with ipilimumab (1 mg/kg) every 6 weeks. The results of this study should clarify the therapeutic potential of NIVO+IPI for MSI-H GC in the first-line setting. Trial registration: JapicCTI-205400.

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“…The PFS2, defined by time from randomization to progression on next line of therapy (second line if received),or death was not reached in the pembrolizumab arm and 23.5 moths in the chemotherapy arm [ 30 ]. Pembrolizumab monotherapy led to clinically meaningful improvements in health-related quality of life compared with chemotherapy in patients with previously untreated MSI-H/dMMR mCRC [ 31 ].…”

Section: Immune Checkpoint Inhibitors In Msi/dmmr Mcrcmentioning

confidence: 99%

Immune Checkpoint Inhibition in Metastatic Colorectal Cancer Harboring Microsatellite Instability or Mismatch Repair Deficiency

Cohen

Colle

Pudlarz

et al. 2021

Cancers

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Microsatellite instability (MSI) is a tumor phenotype related to a deficient DNA mismatch repair system (dMMR). This phenotype, observed in 5% of metastatic mCRC but 10–18% of localized CRC, is associated with high tumor mutational burden with highly immunogenic neoantigens. It has emerged as a major predictive biomarker for the efficacy of ICIs. In this review, we will present a comprehensive overview of the literature concerning the efficacy of ICIs in MSI/dMMR mCRC, with a focus on new developments in first-line metastatic setting. Then, we will present current and future challenges of immuno-oncology for patients with MSI/dMMR metastatic CRC.

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396O Health-related quality of life (HRQoL) in patients (pts) treated with pembrolizumab (pembro) vs chemotherapy as first-line treatment in microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC): Phase III KEYNOTE-177 study

Abstract: 396OHealth-related quality of life (HRQoL) in patients (pts) treated with pembrolizumab (pembro) vs chemotherapy as first-line treatment in microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC): Phase III

Cited by 9 publications

References 0 publications

Precision Oncology: a Clinical and Patient Perspective

Precision Oncology: a Clinical and Patient Perspective

An Investigator-Initiated Phase 2 Study of Nivolumab Plus Low-Dose Ipilimumab as First-Line Therapy for Microsatellite Instability—High Advanced Gastric or Esophagogastric Junction Cancer (NO LIMIT, WJOG13320G/CA209-7W7)

Immune Checkpoint Inhibition in Metastatic Colorectal Cancer Harboring Microsatellite Instability or Mismatch Repair Deficiency

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