Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001–02)

Aparicio, Thomas; Lavau‐Denès, Sandrine; Phélip, Jean-Marc; Maillard, E.; Jouve, Jean-Louis; Gargot, D.; Gasmi, Mohamed; Locher, Christophe; Adhoute, Xavier; Michel, Pierre; Khemissa, Faïza; Lecomte, Thierry; Provençal, J.; Breysacher, Gilles; Legoux, Jean-Louis; Lepère, Céline; Charneau, J; Crétin, J; Choné, Laurence; Azzedine, A.; Bouché, Olivier; Sobhani, Iradj; Bedenne, Laurent; Mitry, Emmanuel; Amoyal, P.; Auby, Dominique; Bachet, Jean‐Baptiste; Baconnier, Mathieu; Benoit, R.; Berthelet, Olivier; Bidault, Anne Thirot; Bineau, Catherine; Bordes, Gilbert; Bouarioua, Nadia; Boucher, Éveline; Boulat, Olivier; Cléau, D.; Couzigou, Patrice; Cuillerier, Emmanuel; Cumin, Isabelle; Denis, Bernard; Fiore, Frédéric Di; Derias, V.; Ezenfis, J.; Faroux, Roger; Gagnaire, Alice; Gatineau-Sailliant, Gilles; Garcia, Bruno; Genet, Dominique; Gueye, A.; Hammel, Pascal; Lagasse, Jean-Paul; Landi, Bruno; Lepage, Côme; Lobry, Céline; Lombard‐Bohas, Catherine; Mabro, May; Mackiewicz, R; Martin, J. M. Artigas; Moncoucy, Xavier; Morvan, F.; Mozer, M.; Pauwels, Martine; Petit-Laurent, Fabien; Pouderoux, Philippe; Prost, Patricia; Queuniet, A M; Ramdani, Mohamed; Rebischung, Christine; Rougier, Philippe; Schnee, Matthieu; Seitz, Jean‐François; Stefani, Laëtitia; Taı̈eb, Julien; Terrebonne, Éric; Texereau, Patrick; Thaury, J.; Tougeron, David; Weber, Ana Paula; Ricard, F.; Bonnetain, Franck; Masskouri, F.; Choine, C.; Guiliani, F.; Pessec, G. Le; Fattouh, H.; Provost, Nicolas; Girault, Cécile; Schneider, Martina

doi:10.1093/annonc/mdv491

Cited by 84 publications

(65 citation statements)

References 24 publications

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“…In the present study, OS was not significantly different between the patients who received mono-chemotherapy ( n = 16, 42.1%) and combination chemotherapy ( n = 22, 57.9%). We report results consistent with those of previous studies [5, 29]; mono-chemotherapy might be acceptable for these patients. However, randomized prospective studies are still needed to further determine the optimal chemotherapy regimen for elderly patients with stage IV CRC.…”

Section: Discussionsupporting

confidence: 92%

“…This is similar to the result previously reported in another study [5]. Regarding the chemotherapy regimen, some studies reported that combination chemotherapy was not superior to monotherapy in terms of OS in elderly patients with metastatic CRC [5, 29]. In the present study, OS was not significantly different between the patients who received mono-chemotherapy ( n = 16, 42.1%) and combination chemotherapy ( n = 22, 57.9%).…”

Section: Discussionsupporting

confidence: 91%

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High Serum CA19-9 Concentration Predicts Poor Prognosis in Elderly Patients with Stage IV Colorectal Cancer

Hidaka

Maeda

Nakahara

et al. 2018

Gastrointest Tumors

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Background/Aim: The optimal treatment strategy for elderly patients with stage IV colorectal cancer (CRC) remains controversial due to limited research data. The purpose of this study was to evaluate treatment results and to clarify the prognostic factors, especially poor prognosis factors, in elderly patients with stage IV CRC. Methods: We retrospectively reviewed the data of 82 elderly patients (aged ≥75 years) with stage IV CRC who underwent surgical treatment at our hospital between April 2001 and March 2017. Factors that affected prognosis and the ability to undergo treatment were analyzed via multivariate analysis. Results: The median overall survival (OS) in the patients with high pretreatment serum carbohydrate antigen 19-9 (CA19-9) concentration (> 370 U/mL) was significantly worse than in those with lower serum CA19-9 concentration (0–370 U/mL) (8.5 vs. 19.2 months, p = 0.0059). In univariate analysis, age (≥80 years) (p = 0.014), performance status of 1–3 (p = 0.028), and high pretreatment serum CA19-9 concentration (p = 0.014) were significant prognostic factors for poor OS. By contrast, resection of the primary tumor (p = 0.024), chemotherapy (p < 0.0001), and resection of distant metastasis (p = 0.0005) were significant prognostic factors for favorable OS. Multivariate analysis showed that a high pretreatment serum CA19-9 concentration was an independent prognostic factor for poor OS (p = 0.01). Meanwhile, resection of the primary tumor (p = 0.033), chemotherapy (p < 0.0001), and resection of distant metastasis (p = 0.0008) were prognostic factors for favorable OS. Conclusions: A high pretreatment serum CA19-9 concentration (> 370 U/mL) was a reliable predictive factor for poor prognosis, and aggressive treatments should be performed carefully in these patients. Moreover, various treatments, including surgery and chemotherapy, might improve OS in elderly patients with stage IV CRC.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

High Serum CA19-9 Concentration Predicts Poor Prognosis in Elderly Patients with Stage IV Colorectal Cancer

Hidaka

Maeda

Nakahara

et al. 2018

Gastrointest Tumors

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“…Irinotecan-containing regimens are considered for metastatic colorectal cancer instead of adjuvant chemotherapy regimens [61][62][63]. Furthermore, rates of grade 3 or 4 toxicity were also significantly higher with irinotecan, with higher rates of neutropenia, febrile neutropenia, and diarrhea [64]. Regimens combining irinotecan with bolus fluoropyrimidine and leucovorin are even more toxic and twice as likely to have severe neutropenia [64,65].…”

Section: Discussionmentioning

confidence: 99%

Adjuvant Therapy for High-Risk Stage II or III Colon Adenocarcinoma: A Propensity Score-Matched, Nationwide, Population-Based Cohort Study

Chang

Yuan

et al. 2019

Cancers

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Purpose: To determine the optimal adjuvant chemotherapy regimen for patients with high-risk stage II or III colon adenocarcinoma, we conducted this propensity score-matched, nationwide, population-based cohort study to estimate the effects of adjuvant treatments in high-risk stage II or III colon adenocarcinoma. Patients and Methods: Using propensity score matching, we minimized the confounding effects of sex, age, pathologic stage, tumor location, total chemotherapy cycles, and Charlson comorbidity index scores on adjuvant treatment outcomes in patients with high-risk stage II or III resectable colon adenocarcinoma. We selected the patients from the Taiwan Cancer Registry database and divided them into four groups: Group 1, comprising patients who received surgery alone; group 2, comprising those who received adjuvant fluoropyrimidine alone; group 3, comprising those who received adjuvant oxaliplatin-fluoropyrimidine-leucovorin (FOLFOX); and group 4, comprising those who received adjuvant folinic acid-fluorouracil-irinotecan (FOLFIRI). Results: In both univariate and multivariate Cox regression analyses, the adjusted hazard ratios (aHRs, as well as the 95% confidence intervals (Cis)) for mortality observed for groups 1, 2, and 4 relative to group 3 were 1.55 (1.32 to 1.82), 1.22 (1.05 to 1.43), and 2.97 (2.43 to 3.63), respectively. After a stratified subgroup analysis for high-risk stage II colon adenocarcinoma, we noted that the aHR (95% CI) for mortality for group 2 relative to group 3 was 0.52 (0.30 to 0.89). Conclusions: Adjuvant fluoropyrimidine alone is the most optimal regimen for patients with high-risk stage II colon adenocarcinoma compared with the other adjuvant chemotherapy regimens. Adjuvant FOLFOX can serve as an optimal regimen for patients with pathologic stage III colon adenocarcinoma, regardless of age, sex, or tumor location.

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“…As in clinical trials, older patients may be partly excluded from receiving treatment with targeted therapies in real‐life settings. The unwillingness of physicians to prescribe anticancer medications in older adults may be greater with regard to newer medications, as recently demonstrated by McCleary et al 11 However, there is increasing evidence of a satisfactory benefit‐risk ratio of such medications in this population . Except for age, other factors that may influence the decision to prescribe conventional chemotherapy alone or a treatment including a targeted therapy were related to mCRC.…”

Section: Discussionmentioning

confidence: 98%

“…The unwillingness of physicians to prescribe anticancer medications in older adults may be greater with regard to newer medications, as recently demonstrated by McCleary et al 11 However, there is increasing evidence of a satisfactory benefitrisk ratio of such medications in this population. 9,10,12,[22][23][24] Except for age, other factors that may influence the decision to prescribe conventional chemotherapy alone or a treatment including a targeted therapy were related to mCRC. Intensive treatment, including a targeted therapy, may be avoided in patients with a history of cancer because of previous exposure to chemotherapy or radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Gouverneur

Bezin

Jové

et al. 2019

J American Geriatrics Society

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OBJECTIVES Metastatic colorectal cancer (mCRC) is increasingly treated with targeted therapies, but little is known about real‐life mCRC treatment in older adults. The aims were to describe the real‐life first‐line treatment modalities in older adult mCRC patients, to identify factors associated with treatment modalities, and to evaluate survival with regard to treatment modalities. PATIENTS AND METHODS A cohort of mCRC patients aged 65 years and older at diagnosis was identified between 2009 and 2013 using French national healthcare insurance system claims data. Treatment modalities were: treatment with one or more anticancer medication vs best supportive care and, among treated patients, treatment with targeted therapy vs conventional chemotherapy alone. Multivariate logistic regression was used to identify factors associated with treatment by anticancer medication and by targeted therapy. Cox proportional hazards models were used to assess the independent effect of treatment modalities on overall survival while adjusting for baseline covariates identified with logistic regression. RESULTS A total of 503 patients were included with a median age of 78 years (54% were men). Of these, 299 (59%) were treated with anticancer medications. Among treated patients, 131 (44%) received targeted therapy. In multivariate analysis, age 75 years or older, renal failure, malnutrition, and five or more concomitant medications were associated with a lower likelihood of treatment with anticancer medications. Among treated patients, age 75 years or older, history of cancer, lymph node metastases, and a single metastatic site were associated with a lower likelihood of treatment with targeted therapy. Multivariate Cox proportional hazards models found that treatment with any anticancer medication tended to be associated with a lower risk of death; treatment with targeted therapy was not significantly associated. CONCLUSION A more appropriate prescription of anticancer medications in the older adult will require the definition of more explicit criteria to avoid undertreatment. The real benefit of targeted therapies vs conventional chemotherapy alone needs to be confirmed in this population. J Am Geriatr Soc 67:913–919, 2019.

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Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001–02)

Cited by 84 publications

References 24 publications

High Serum CA19-9 Concentration Predicts Poor Prognosis in Elderly Patients with Stage IV Colorectal Cancer

High Serum CA19-9 Concentration Predicts Poor Prognosis in Elderly Patients with Stage IV Colorectal Cancer

Adjuvant Therapy for High-Risk Stage II or III Colon Adenocarcinoma: A Propensity Score-Matched, Nationwide, Population-Based Cohort Study

Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

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