Patient baseline characteristics in the PROMETCO study:
A real-world, prospective longitudinal cohort on the continuum
of care of metastatic colorectal cancer
Data presented at the ESMO World Congress on Gastrointestinal Cancer 20211 and the ASCO Gastrointestinal Cancers Symposium 20222
1. Koopman M, et al. Patient baseline characteristics in the PROMETCO study: A real-world, prospective longitudinal cohort on the continuum of care of metastatic colorectal cancer. Poster presented at: ESMO World Congress on Gastrointestinal Cancer; June 30 to July 3, 2021; 2. Bachet JB, et al. Baseline treatment patterns of the first 277 patients in PROMETCO: A real-world, prospective, longitudinal cohort study on the continuum of care in metastatic colorectal cancer (mCRC). Poster presented at: ASCO Gastrointestinal Cancers Symposium; January 20–22, 2022.
PROMETCO: Study background and aim
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PROMETCO (NCT03935763) is the first international, prospective real-world study to investigate the continuum
of care in the mCRC patient population, collecting data on all patients regardless of treatment -
PROMETCO will evaluate the OS of patients with mCRC, the patterns, effectiveness and safety of mCRC treatments, the reasons
behind changes or discontinuation in treatment, adherence to treatment guidelines, healthcare resource utilisation and PROs
Aim: To present initial baseline characteristics and real-world treatment patterns by biomolecular status of the first 277 patients
enrolled in the PROMETCO study, as of October 1, 2020
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Inclusion criteria: Adult patients with two disease progressions
since the first diagnosis of metastatic disease
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Exclusion criteria: Patients enrolled in other clinical trials, those receiving
treatment for other cancers or those with insufficient mental capacity
ECOG PS, Eastern Cooperative Oncology Group performance status; mCRC, metastatic colorectal cancer; OS, overall survival; PRO, patient-reported outcome.
Patients in the overall study population (N=277) by country
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Biomolecular status of patients in PROMETCO
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Overall population (N=277)
*Two patients had RAF and BRAF mutations.
MSI, microsatellite instability; MSS, microsatellite stable.
Age and sex distribution in PROMETCO
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Click on the following indication to see the data
Overall
RAS mutation
BRAF mutation
RAS/BRAF
wildtype
MSI high
MSI low
MSS
Overall population (N=276)*
*Missing data: n=1.
MSI, microsatellite instability; MSS, microsatellite stable.
RAS mutation (n=146)
MSI, microsatellite instability; MSS, microsatellite stable.
BRAF mutation (n=7)*
*Missing data: n=1.
MSI, microsatellite instability; MSS, microsatellite stable.
RAS/BRAF wildtype (n=81)
MSI, microsatellite instability; MSS, microsatellite stable.
MSI high (n=2)
MSI, microsatellite instability; MSS, microsatellite stable.
MSI low (n=2)
MSI, microsatellite instability; MSS, microsatellite stable.
MSS (n=131)*
*Missing data: n=1.
MSI, microsatellite instability; MSS, microsatellite stable.
ECOG PS in PROMETCO
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Click on the following indication to see the data
Overall
RAS mutation
BRAF mutation
RAS/BRAF
wildtype
MSI high
MSI low
MSS
Overall population (N=277)
*Percentages do not include ND values (n=267).
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
RAS mutation (n=146)
*Percentages do not include ND values (n=141).
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
BRAF mutation (n=8)*
*Insufficient numbers to make an interpretation on the percentage of patients with ECOG PS 0–1; †Percentages do not include ND values (n=6).
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
RAS/BRAF wildtype (n=81)
*Percentages do not include ND values (n=80).
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
MSI high (n=2)*
*Insufficient numbers to make an interpretation on the percentage of patients with ECOG PS 0–1.
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
MSI low (n=2)*
*Insufficient numbers to make an interpretation on the percentage of patients with ECOG PS 0–1.
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
MSS (n=132)
*Percentages do not include ND values (n=126).
ECOG PS, Eastern Cooperative Oncology Group performance status; MSI, microsatellite instability; MSS, microsatellite stable; ND, not determined.
Baseline disease characteristics in PROMETCO
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Click on the following indication to see the data
Overall
RAS mutation
BRAF mutation
RAS/BRAF
wildtype
MSI high
MSI low
MSS
Overall population (N=277)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*n=275 with available data; †n=276 with available data; ‡Includes brain and skin metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
Overall population (N=277)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*n=275 with available data.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
Overall population (N=277)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
RAS mutation (n=146)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*n=145 with available data; †Includes brain and skin metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
RAS mutation (n=146)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*n=145 with available data.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
RAS mutation (n=146)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
BRAF mutation (n=8)*
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Insufficient numbers to make an interpretation; †Includes brain and skin metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
BRAF mutation (n=8)*
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Insufficient numbers to make an interpretation.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
BRAF mutation (n=8)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
RAS/BRAF wildtype (n=81)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Includes brain and skin metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
RAS/BRAF wildtype (n=81)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
RAS/BRAF wildtype (n=81)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSI high (n=2)*
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Insufficient numbers to make an interpretation; †Includes brain, skin and bone metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSI high (n=2)*
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Insufficient numbers to make an interpretation.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSI high (n=2)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSI low (n=2)*
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Insufficient numbers to make an interpretation; †Includes brain, skin and bone metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSI low (n=2)*
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Insufficient numbers to make an interpretation.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSI low (n=2)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSS (n=132)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
*Includes brain, skin and bone metastases.
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSS (n=132)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
MSS (n=132)
Metastatic characteristics
Disease sidedness
Time between mCRC
diagnosis and inclusion
mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable.
Real-world treatment patterns prior to enrollment in PROMETCO
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Click on the following indication to see the data
Overall
RAS mutation
BRAF mutation
RAS/BRAF
wildtype
MSI high
MSI low
MSS
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
Overall population (n=257)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=20; †Duration of treatment in months was calculated by converting days to months using a 30.44:1 ratio. A patient could have multiple treatments for each treatment line; ‡Missing data: n=1.
max, maximum; min, minimum; MSI, microsatellite instability; MSS, microsatellite stable; Q, quartile.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
Overall population (n=257)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=20.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; ESMO, European Society for Medical Oncology; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
1. Van Cutsem E, et al. Ann Oncol. 2016;27:1386–422.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
Overall population (n=257)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=20.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; mCRC, metastatic colorectal cancer; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
RAS mutation (n=135)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=11; †Duration of treatment in months was calculated by converting days to months using a 30.44:1 ratio. A patient could have multiple treatments for each treatment line; ‡Missing data: n=1.
max, maximum; min, minimum; MSI, microsatellite instability; MSS, microsatellite stable; Q, quartile.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
RAS mutation (n=135)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=11; †One patient received FOLFIRI + anti-EGFR.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; ESMO, European Society for Medical Oncology; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
1. Van Cutsem E, et al. Ann Oncol. 2016;27:1386–422.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
RAS mutation (n=135)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=11.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
RAS/BRAF wildtype (n=76)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=5; †Duration of treatment in months was calculated by converting days to months using a 30.44:1 ratio. A patient could have multiple treatments for each treatment line; ‡Missing data: n=1.
max, maximum; min, minimum; MSI, microsatellite instability; MSS, microsatellite stable; Q, quartile.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
RAS/BRAF wildtype (n=76)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=5.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
RAS/BRAF wildtype (n=76)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=5.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
MSS (n=124)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=8; †Duration of treatment in months was calculated by converting days to months using a 30.44:1 ratio. A patient could have multiple treatments for each treatment line; ‡Missing data: n=1.
max, maximum; min, minimum; MSI, microsatellite instability; MSS, microsatellite stable; Q, quartile.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
MSS (n=124)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=8.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5-fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
Due to patients with no/undocumented previous treatment and the low number of patients,
data are not presented for the BRAF mutation, MSI high, and MSI low groups
MSS (n=124)*
Duration of treatment
First-line treatment
Second-line treatment
*Patients with no/undocumented previous treatment: n=8.
Regimens: anti-VEGF = bevacizumab and aflibercept; anti-EGFR = cetuximab and panitumumab.
5-FU, 5- fluorouracil; BEV, bevacizumab; CAP, capecitabine; CT, chemotherapy; EGFR, epidermal growth factor receptor; FOLFIRI, folinic acid + 5-FU + irinotecan; FOLFIRINOX/FOLFOXIRI, folinic acid + 5-FU + irinotecan + oxaliplatin; FOLFOX, folinic acid + 5-FU + oxaliplatin; IRI, irinotecan; MSI, microsatellite instability; MSS, microsatellite stable; OXA, oxaliplatin; VEGF, vascular endothelial growth factor.
Conclusions
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Preliminary data from the PROMETCO trial provide key insights on the baseline demographics, disease characteristics, molecular status and prior treatment patterns of real-world patients with mCRC
RAS/BRAF molecular testing is routinely performed (with only 15% having an unknown status). However, for MSI molecular testing, there is a significant proportion with an unknown status (50.9%), which could potentially influence the choice of treatment and subsequent treatment sequencing
The mean age at diagnosis for the overall study population is 66 years, which is in line with the high range reported in a systematic literature review of seven clinical studies (median age range, 56–67 years)1
Tumours on the right side occur less frequently (28.0–44.0%) than on the left, in this initial assessment of the population. This is in line with a subgroup analysis of 12 randomized trials (26.1–73.9%).2 Further analysis on a larger population will be interesting to determine sidedness/mutational status and how this affects treatment sequence and prognostic features
Prior to inclusion in PROMETCO, the majority of patients received CT doublet/triplet + anti-VEGF/EGFR therapy as first- and second-line treatment, which is in line with international/ESMO guidelines.3 Some patients received third- and fourth-line treatment
It is anticipated that PROMETCO will provide valuable data on OS, treatment patterns, effectiveness, safety, adherence to treatment guidelines, healthcare resource utilization and PROs in this patient population
CT, chemotherapy; EGFR, epidermal growth factor receptor; ESMO, European Society for Medical Oncology; mCRC, metastatic colorectal cancer; MSI, microsatellite instability; OS, overall survival; PRO, patient-reported outcome; VEGF, vascular endothelial growth factor.
1. Walter T, et al. J Cancer Res Clin Oncol. 2020;146(10):2575–87; 2. Yin J, et al. J Natl Cancer Inst. 2021;djab112; 3. Van Cutsem E, et al. Ann Oncol. 2016;27(8):1386–422.
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