Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation

David M Waterhouse; Sacha Rothschild; Christophe Dooms; Bertrand Mennecier; Farastuk Bozorgmehr; Margarita Majem; Michel H van den Heuvel; Helena Linardou; Byoung Chul Cho; Rachel Roberts-Thomson; Kentaro Tanaka; Normand Blais; Gustavo Schvartsman; Karin Holmskov Hansen; Izabela Chmielewska; Martin D Forster; Christina Giannopoulou; Björn Stollenwerk; Cynthia C Obiozor; Yang Wang; Silvia Novello

doi:10.1016/j.lungcan.2024.107921

Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation

David M Waterhouse
, Sacha Rothschild
, Christophe Dooms
, Bertrand Mennecier
, Farastuk Bozorgmehr
, Margarita Majem
, Michel H van den Heuvel
, Helena Linardou
, Byoung Chul Cho
, Rachel Roberts-Thomson
, Kentaro Tanaka
, Normand Blais
, Gustavo Schvartsman
, Karin Holmskov Hansen
, Izabela Chmielewska
, Martin D Forster
, Christina Giannopoulou
, Björn Stollenwerk
, Cynthia C Obiozor
, Yang Wang

Silvia Novello

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: In the CodeBreaK 200 phase III, open-label trial, sotorasib significantly improved efficacy versus docetaxel in previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Patient-reported outcomes (PROs) for global health status, physical functioning, dyspnea, and cough favored sotorasib over docetaxel. Here, we report sotorasib's additional impact on quality of life (QOL).

METHODS: In CodeBreaK 200, 345 patients who had progressed after prior therapy received sotorasib (960 mg orally daily) or docetaxel (75 mg/m2 intravenously every 3 weeks). Validated questionnaires captured patients' perception of their QOL and symptom burden for key secondary and exploratory PRO endpoints, including the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Quality-of-life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13), question GP5 from the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and 5-level EuroQOL-5 dimensions (EQ-5D-5L) including visual analog scale (EQ-5D VAS). Change from baseline to week 12 was assessed with generalized estimating equations for ordinal outcomes.

RESULTS: Patients receiving sotorasib were less bothered by treatment side effects than those receiving docetaxel (odds ratio [OR] 5.7) and experienced symptoms at lower severity (pain: OR 2.9; aching muscles: OR 4.4; aching joints: OR 4.2; mouth or throat sores: OR 4.3). Further, patients' symptoms interfered less with usual/daily activities (pain: OR 3.2; aching muscles: OR 3.9; aching joints: OR 10.7). QOL remained stable with sotorasib but worsened with docetaxel (change from baseline in EQ-5D VAS score: 1.5 vs -8.4 at cycle 1 day 5 and 2.2 vs -5.8 at week 12).

CONCLUSIONS: Patients receiving sotorasib reported less severe symptoms than those receiving docetaxel. In addition to improving clinical efficacy outcomes, sotorasib maintained QOL versus docetaxel, suggesting sotorasib may be a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC.

Original language	English
Article number	107921
Pages (from-to)	107921
Journal	Lung Cancer
Volume	196
DOIs	https://doi.org/10.1016/j.lungcan.2024.107921
Publication status	Published - Oct 2024
Externally published	Yes

Keywords

Adult
Aged
Aged, 80 and over
Antineoplastic Agents/therapeutic use
Carcinoma, Non-Small-Cell Lung/drug therapy
Docetaxel/therapeutic use
Female
Humans
Lung Neoplasms/drug therapy
Male
Middle Aged
Mutation
Neoplasm Staging
Patient Reported Outcome Measures
Piperazines
Proto-Oncogene Proteins p21(ras)/genetics
Pyridines
Pyrimidines/therapeutic use
Quality of Life
Surveys and Questionnaires
Treatment Outcome

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10.1016/j.lungcan.2024.107921Licence: CC BY-NC

Cite this

Waterhouse, D. M., Rothschild, S., Dooms, C., Mennecier, B., Bozorgmehr, F., Majem, M., van den Heuvel, M. H., Linardou, H., Chul Cho, B., Roberts-Thomson, R., Tanaka, K., Blais, N., Schvartsman, G., Holmskov Hansen, K., Chmielewska, I., Forster, M. D., Giannopoulou, C., Stollenwerk, B., Obiozor, C. C., ... Novello, S. (2024). Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation. Lung Cancer, 196, 107921. Article 107921. https://doi.org/10.1016/j.lungcan.2024.107921

@article{09e003c74ff74ba0bfdedf96720ae43c,

title = "Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation",

abstract = "BACKGROUND: In the CodeBreaK 200 phase III, open-label trial, sotorasib significantly improved efficacy versus docetaxel in previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Patient-reported outcomes (PROs) for global health status, physical functioning, dyspnea, and cough favored sotorasib over docetaxel. Here, we report sotorasib's additional impact on quality of life (QOL).METHODS: In CodeBreaK 200, 345 patients who had progressed after prior therapy received sotorasib (960 mg orally daily) or docetaxel (75 mg/m2 intravenously every 3 weeks). Validated questionnaires captured patients' perception of their QOL and symptom burden for key secondary and exploratory PRO endpoints, including the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Quality-of-life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13), question GP5 from the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and 5-level EuroQOL-5 dimensions (EQ-5D-5L) including visual analog scale (EQ-5D VAS). Change from baseline to week 12 was assessed with generalized estimating equations for ordinal outcomes.RESULTS: Patients receiving sotorasib were less bothered by treatment side effects than those receiving docetaxel (odds ratio [OR] 5.7) and experienced symptoms at lower severity (pain: OR 2.9; aching muscles: OR 4.4; aching joints: OR 4.2; mouth or throat sores: OR 4.3). Further, patients' symptoms interfered less with usual/daily activities (pain: OR 3.2; aching muscles: OR 3.9; aching joints: OR 10.7). QOL remained stable with sotorasib but worsened with docetaxel (change from baseline in EQ-5D VAS score: 1.5 vs -8.4 at cycle 1 day 5 and 2.2 vs -5.8 at week 12).CONCLUSIONS: Patients receiving sotorasib reported less severe symptoms than those receiving docetaxel. In addition to improving clinical efficacy outcomes, sotorasib maintained QOL versus docetaxel, suggesting sotorasib may be a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC.",

keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Agents/therapeutic use, Carcinoma, Non-Small-Cell Lung/drug therapy, Docetaxel/therapeutic use, Female, Humans, Lung Neoplasms/drug therapy, Male, Middle Aged, Mutation, Neoplasm Staging, Patient Reported Outcome Measures, Piperazines, Proto-Oncogene Proteins p21(ras)/genetics, Pyridines, Pyrimidines/therapeutic use, Quality of Life, Surveys and Questionnaires, Treatment Outcome",

author = "Waterhouse, \{David M\} and Sacha Rothschild and Christophe Dooms and Bertrand Mennecier and Farastuk Bozorgmehr and Margarita Majem and \{van den Heuvel\}, \{Michel H\} and Helena Linardou and \{Chul Cho\}, Byoung and Rachel Roberts-Thomson and Kentaro Tanaka and Normand Blais and Gustavo Schvartsman and \{Holmskov Hansen\}, Karin and Izabela Chmielewska and Forster, \{Martin D\} and Christina Giannopoulou and Bj{\"o}rn Stollenwerk and Obiozor, \{Cynthia C\} and Yang Wang and Silvia Novello",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s)",

year = "2024",

month = oct,

doi = "10.1016/j.lungcan.2024.107921",

language = "English",

volume = "196",

pages = "107921",

journal = "Lung Cancer",

issn = "0169-5002",

publisher = "Elsevier Ireland Ltd",

}

Waterhouse, DM, Rothschild, S, Dooms, C, Mennecier, B, Bozorgmehr, F, Majem, M, van den Heuvel, MH, Linardou, H, Chul Cho, B, Roberts-Thomson, R, Tanaka, K, Blais, N, Schvartsman, G, Holmskov Hansen, K, Chmielewska, I, Forster, MD, Giannopoulou, C, Stollenwerk, B, Obiozor, CC, Wang, Y & Novello, S 2024, 'Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation', Lung Cancer, vol. 196, 107921, pp. 107921. https://doi.org/10.1016/j.lungcan.2024.107921

TY - JOUR

T1 - Patient-reported outcomes in CodeBreaK 200

T2 - Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation

AU - Waterhouse, David M

AU - Rothschild, Sacha

AU - Dooms, Christophe

AU - Mennecier, Bertrand

AU - Bozorgmehr, Farastuk

AU - Majem, Margarita

AU - van den Heuvel, Michel H

AU - Linardou, Helena

AU - Chul Cho, Byoung

AU - Roberts-Thomson, Rachel

AU - Tanaka, Kentaro

AU - Blais, Normand

AU - Schvartsman, Gustavo

AU - Holmskov Hansen, Karin

AU - Chmielewska, Izabela

AU - Forster, Martin D

AU - Giannopoulou, Christina

AU - Stollenwerk, Björn

AU - Obiozor, Cynthia C

AU - Wang, Yang

AU - Novello, Silvia

PY - 2024/10

Y1 - 2024/10

N2 - BACKGROUND: In the CodeBreaK 200 phase III, open-label trial, sotorasib significantly improved efficacy versus docetaxel in previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Patient-reported outcomes (PROs) for global health status, physical functioning, dyspnea, and cough favored sotorasib over docetaxel. Here, we report sotorasib's additional impact on quality of life (QOL).METHODS: In CodeBreaK 200, 345 patients who had progressed after prior therapy received sotorasib (960 mg orally daily) or docetaxel (75 mg/m2 intravenously every 3 weeks). Validated questionnaires captured patients' perception of their QOL and symptom burden for key secondary and exploratory PRO endpoints, including the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Quality-of-life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13), question GP5 from the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and 5-level EuroQOL-5 dimensions (EQ-5D-5L) including visual analog scale (EQ-5D VAS). Change from baseline to week 12 was assessed with generalized estimating equations for ordinal outcomes.RESULTS: Patients receiving sotorasib were less bothered by treatment side effects than those receiving docetaxel (odds ratio [OR] 5.7) and experienced symptoms at lower severity (pain: OR 2.9; aching muscles: OR 4.4; aching joints: OR 4.2; mouth or throat sores: OR 4.3). Further, patients' symptoms interfered less with usual/daily activities (pain: OR 3.2; aching muscles: OR 3.9; aching joints: OR 10.7). QOL remained stable with sotorasib but worsened with docetaxel (change from baseline in EQ-5D VAS score: 1.5 vs -8.4 at cycle 1 day 5 and 2.2 vs -5.8 at week 12).CONCLUSIONS: Patients receiving sotorasib reported less severe symptoms than those receiving docetaxel. In addition to improving clinical efficacy outcomes, sotorasib maintained QOL versus docetaxel, suggesting sotorasib may be a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC.

AB - BACKGROUND: In the CodeBreaK 200 phase III, open-label trial, sotorasib significantly improved efficacy versus docetaxel in previously treated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). Patient-reported outcomes (PROs) for global health status, physical functioning, dyspnea, and cough favored sotorasib over docetaxel. Here, we report sotorasib's additional impact on quality of life (QOL).METHODS: In CodeBreaK 200, 345 patients who had progressed after prior therapy received sotorasib (960 mg orally daily) or docetaxel (75 mg/m2 intravenously every 3 weeks). Validated questionnaires captured patients' perception of their QOL and symptom burden for key secondary and exploratory PRO endpoints, including the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Quality-of-life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13), question GP5 from the Functional Assessment of Cancer Therapy Tool General Form (FACT-G GP5), PRO-Common Terminology Criteria for Adverse Events (PRO-CTCAE), and 5-level EuroQOL-5 dimensions (EQ-5D-5L) including visual analog scale (EQ-5D VAS). Change from baseline to week 12 was assessed with generalized estimating equations for ordinal outcomes.RESULTS: Patients receiving sotorasib were less bothered by treatment side effects than those receiving docetaxel (odds ratio [OR] 5.7) and experienced symptoms at lower severity (pain: OR 2.9; aching muscles: OR 4.4; aching joints: OR 4.2; mouth or throat sores: OR 4.3). Further, patients' symptoms interfered less with usual/daily activities (pain: OR 3.2; aching muscles: OR 3.9; aching joints: OR 10.7). QOL remained stable with sotorasib but worsened with docetaxel (change from baseline in EQ-5D VAS score: 1.5 vs -8.4 at cycle 1 day 5 and 2.2 vs -5.8 at week 12).CONCLUSIONS: Patients receiving sotorasib reported less severe symptoms than those receiving docetaxel. In addition to improving clinical efficacy outcomes, sotorasib maintained QOL versus docetaxel, suggesting sotorasib may be a more tolerable treatment option for patients with pretreated, KRAS G12C-mutated advanced NSCLC.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents/therapeutic use

KW - Carcinoma, Non-Small-Cell Lung/drug therapy

KW - Docetaxel/therapeutic use

KW - Female

KW - Humans

KW - Lung Neoplasms/drug therapy

KW - Male

KW - Middle Aged

KW - Mutation

KW - Neoplasm Staging

KW - Patient Reported Outcome Measures

KW - Piperazines

KW - Proto-Oncogene Proteins p21(ras)/genetics

KW - Pyridines

KW - Pyrimidines/therapeutic use

KW - Quality of Life

KW - Surveys and Questionnaires

KW - Treatment Outcome

U2 - 10.1016/j.lungcan.2024.107921

DO - 10.1016/j.lungcan.2024.107921

M3 - Article

C2 - 39303400

SN - 0169-5002

VL - 196

SP - 107921

JO - Lung Cancer

JF - Lung Cancer

M1 - 107921

ER -

Patient-reported outcomes in CodeBreaK 200: Sotorasib versus docetaxel for previously treated advanced NSCLC with KRAS G12C mutation

Abstract

Keywords

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