Health-Related Quality of Life Impact of Bevacizumab When Combined with Irinotecan, 5-Fluorouracil, and Leucovorin or 5-Fluorouracil and Leucovorin for Metastatic Colorectal Cancer

Wallace, Joel; Holmgren, Eric; Yi, Jing; Cella, David; Yost, Kathleen J.; Hurwitz, Herbert I.

doi:10.1634/theoncologist.2008-0003

Cited by 39 publications

(23 citation statements)

References 15 publications

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“…Similar data have also been reported in three studies of bevacizumab. In first-line mCRC patients, except one measure in one phase II study, the time to deterioration in HRQoL did not differ significantly between patients receiving bevacizumab combined with 5-fluorouracil(5-FU)/leucovorin, irinotecan/5-FU/leucovorin or capecitabine compared with the use of these chemotherapies alone (Kabbinavar et al , 2008; Tebbutt et al , 2010). …”

Section: Discussionmentioning

confidence: 98%

“…Recent advances in the development of treatments for metastatic colorectal cancer (mCRC) have led to improved outcomes in this group of patients (Hurwitz et al , 2004; Amado et al , 2008; Kabbinavar et al , 2008; Karapetis et al , 2008; Saltz et al , 2008; Bokemeyer et al , 2009; Van Cutsem et al , 2009; Tebbutt et al , 2010). Panitumumab, a fully human monoclonal antibody (mAb) targeting the epidermal growth factor receptor (EGFR), originally demonstrated improved progression-free survival (PFS) in combination with best supportive care (BSC) vs BSC alone in patients with wild-type KRAS chemorefractory mCRC (Amado et al , 2008).…”

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confidence: 99%

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Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment

et al. 2011

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Background:Panitumumab in combination with chemotherapy was evaluated in two pivotal clinical trials in first- and second-line treatment of metastatic colorectal cancer (mCRC), respectively. This analysis compared the health-related quality of life (HRQoL) of patients with or without panitumumab in the two trials.Methods:Patients with mCRC were randomised to FOLFOX (first-line trial) or FOLFIRI (second-line trial)±panitumumab. The EuroQoL 5-Dimensions Health State Index (EQ-5D HSI) and Visual Analogue Scale (EQ-5D VAS) were assessed at baseline and monthly follow-up until disease progression. Patients with wild-type KRAS mCRC with baseline and post-baseline HRQoL scores were included. Difference in change from baseline between treatment groups was evaluated using linear mixed and pattern-mixture models.Results:In the first-line trial, 576 patients with wild-type KRAS mCRC (284 panitumumab+FOLFOX4 and 292 FOLFOX4 alone) were included in the HRQoL analyses. In the second-line trial, 530 patients with wild-type KRAS mCRC were included in these analyses (263 panitumumab+FOLFIRI and 267 FOLFIRI alone). There was no significant difference in the change in EQ-5D HSI and VAS scores between treatment groups in either trial.Conclusion:The addition of panitumumab to FOLFOX4 or FOLFIRI in first- or second-line treatment of wild-type KRAS mCRC significantly improved progression-free survival without compromising HRQoL.

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Section: Discussionmentioning

confidence: 98%

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confidence: 99%

Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment

et al. 2011

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“…Kabbinavar et al examined the time to deterioration of health care–related QoL using the colorectal cancer subscale or Trial Outcome Index score, examining two studies with, respectively, 822 and 209 patients. Patients were randomized to receive either irinotecan, 5-fluorouracil, and leucovorin or irinotecan, 5-fluorouracil, leucovorin, and bevacizumab, suggesting that the addition of bevacizumab did not add to patients' treatment burden [29].…”

Section: Discussionmentioning

confidence: 99%

Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study

et al. 2017

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Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Recurrence after resection of colorectal liver metastases (CRLMs), presumably caused by VEGF-mediated outgrowth of micrometastases, might decrease when VEGF is inhibited. This study examines the efficacy and safety of adding bevacizumab to an adjuvant regimen of CAPOX in patients undergoing radical resection for their CRLMs. Patients with resected CRLMs were randomized after surgery to receive CAPOX and bevacizumab (arm A) or CAPOX alone (arm B) as adjuvant treatment. CAPOX was given in both arms for a total of eight cycles. Bevacizumab was administered for 16 cycles. The primary end point was disease-free survival (DFS). Secondary outcomes were overall survival (OS), toxicity, and quality of life (QoL). In total, 79 patients were randomized. At the time of analysis, 23 events were encountered in arm A and 20 in arm B. One-year DFS rate was 79% [95% confidence interval (CI): 68%-93%] and 68% (95% CI: 55%-85%) for arm A and B, respectively (P = .89). Toxicity was evaluated for 75 patients. No significant differences in toxicity between the two arms were found. QoL scores were higher in arm A, of which emotional functioning and global QoL scores were significant. Adding bevacizumab to a CAPOX regimen in patients undergoing a resection for their CLM is safe and showed higher QoL scores compared with CAPOX alone. Because of premature closure of the study, conclusions about the effect on DFS of additional VEGF inhibition in this setting could not yet be made.

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“…0,09-0,25) nella popolazione complessiva, e 0,22 (IC95%: 0,12-0,32) nei pazienti KRAS wild-type. Uno studio clinico di fase III, che ha randomizzato pazienti affetti da CRC metastatico di prima linea al trattamento con 5-FU + irinotecan + leucovorina (IFL) in combinazione o non con bevacizumab, ha valutato gli esiti clinici e la qualità di vita attraverso il time to deterioration [119]. Il deterioramento, o peggioramento della QoL, è stato definito in termini di riduzione dei punteggi ai seguenti questionari: -3 punti di riduzione al CCS (Colorectal Cancer Subscale); -7 punti di riduzione al TOI-C (Trial Outcome Index); -9 punti di riduzione al FACT-C (Functional Assessment of Cancer Therapy-Colorectal).…”

Section: Qualità DI Vita Nei Soggetti Affetti Da Crcunclassified

Cetuximab in first line treatment of metastatic colorectal cancer

Barone

Belisari²,

Ciardiello

et al. 2012

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The present health technology assessment report evaluates the clinical and economic profile of cetuximab in first-line metastatic colorectal cancer (mCRC) in Italy. The first part of the report addresses the epidemiological, clinical, social and economic impact of mCRC. In the second part, evidence of efficacy, safety and cost-effectiveness of cetuximab and its available alternatives is shown. Finally, a model-based economic evaluation aimed at comparing cetuximab-based regimens vs. alternative therapeutic strategies indicated in mCRC in Italy is presented. The model estimates the incremental cost-effectiveness of adding cetuximab to FOLFOX-4 or FOLFIRI based on KRAS status, vs. adding bevacizumab to FOLFOX-4 or vs. FOLFOX-4 or FOLFIRI alone. A theoretical analysis vs. panitumumab has also been performed, despite panitumumab is not yet reimbursed in Italy in first-line mCRC. Survival outcomes, quality of life and costs of patient management are estimated through a Markov model, using the Italian National Healthcare Service (NHS) perspective, over a 10 year period, taking into account KRAS status of patients. The results of the pharmaco-economic analysis show that cetuximab + FOLFOX-4 and cetuximab + FOLFIRI are associated with increased survival, increased cost and increased quality adjusted survival, compared to all other treatments currently indicated and reimbursed in Italy. Adding cetuximab to FOLFOX-4 or FOLFIRI, based on KRAS status shows favorable incremental cost-effectiveness ratio (ICER) vs. adding bevacizumab to FOLFIRI or vs. FOLFOX-4 or FOLFIRI alone. ICER of cetuximab (in combination with FOLFOX-4 or FOLFIRI), compared to currently reimbursed alternatives, is estimated between 6 and 13 thousand Euros per QALY gained, depending on alternative treatment. These estimates are robust in extensive sensitivity analyses. As a final result, both clinical and economic evidence analyzed in this health technology assessment leads to recommend cetuximab as preferred option for the first-line treatment of mCRC KRAS wild-type patients in Italy.

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Health-Related Quality of Life Impact of Bevacizumab When Combined with Irinotecan, 5-Fluorouracil, and Leucovorin or 5-Fluorouracil and Leucovorin for Metastatic Colorectal Cancer

Cited by 39 publications

References 15 publications

Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment

Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment

Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study

Cetuximab in first line treatment of metastatic colorectal cancer

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