First-line single-agent cetuximab in patients with advanced colorectal cancer

Pessino, A.; Artale, Salvatore; Sciallero, Stefania; Guglielmi, Alessandra; Fornarini, Giuseppe; Andreotti, I. C.; Mammoliti, Serafina; Comandini, Danila; Caprioni, Francesco; Bennicelli, E.; Andretta, V.; Siena, Salvatore; Sobrero, Alberto

doi:10.1093/annonc/mdm516

Cited by 41 publications

(22 citation statements)

References 20 publications

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“…This study led to the approval of cetuximab by the regulatory authorities for the treatment of irinotecan refractory metastatic colorectal cancer. Other trials have shown that cetuximab improves survival over best supportive care alone (Jonker et al, 2007) and might offer some advantage in patients receiving first or second line therapy , Pessino et al, 2008. Moreover, it has also proved to be active in combination with oxaliplatin-based regimens, both in the first (Tabernero et al, 2007) and successive lines of treatment (Souglakos et al, 2007) In all those studies, cetuximab was administered weekly with an initial intravenous infusion of 400 mg m À2 on day 1 with subsequent weekly doses of 250 mg m À2 .…”

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confidence: 99%

Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial

et al. 2008

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This is a phase II institutional exploratory trial of biweekly irinotecan and cetuximab administration regimen in metastatic colorectal cancer patients progressing to at least one previous chemotherapy line. A total of 40 patients were treated between November 2005 and November 2007 with irinotecan 180 mg m À2 and cetuximab 500 mg m À2 q2w (every 2 weeks), in every 21-day cycles, until unacceptable toxicity or progressive disease. An overall response rate of 22.5% was obtained (two complete and seven partial responses). The disease control rate was 60%. The time to progression was 3.4 months and the overall survival was 8 months. The toxicity compared very favourably to weekly cetuximab combination schedules. Grade 3/4 adverse effects were observed in 12 patients. Overall, our results turn up very similar both in terms of toxicity and efficacy to those obtained by weekly and biweekly administration regimens.

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confidence: 99%

Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial

et al. 2008

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“…After reviewing each article, a further 56 studies were excluded including those in which combination chemotherapies with cetuximab were conducted and those in which the incidence of skin rash was not described. After final screening, 7 original trials met our inclusion criteria [13, 14, 16, 19,27,28,29]. These studies included randomized controlled studies and single-arm phase II trials (table 1).…”

Section: Resultsmentioning

confidence: 99%

Risk of High-Grade Skin Rash in Cancer Patients Treated with Cetuximab – an Antibody against Epidermal Growth Factor Receptor: Systemic Review and Meta-Analysis

Lacouture²,

Jia

et al. 2009

Oncology

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Background: Cetuximab, a chimeric antibody against epidermal growth factor receptor has emerged as an effective therapy for advanced colorectal cancer (CRC) and head-neck cancer. However, severe skin toxicity may limit its use. Its efficacy in the treatment of other cancers is also undergoing extensive investigation. We performed a systemic review and meta-analysis of published clinical trials to quantify the overall incidence and risk of severe skin rash. Methods: Databases Medline (OVID 1998 to July 2008), Web of Science, and abstracts presented at the American Society of Clinical Oncology conferences from 2004 through July 2008 were searched to identify relevant studies. Eligible studies include phase II and III clinical trials in which patients were treated with a single agent, i.e. cetuximab at 400 mg/m² as initial dose followed by 250 mg/m² weekly. Incidence, relative risk (RR), and 95% confidence intervals (CI) were calculated using a fixed-effects or random-effects model based on the heterogeneity of included studies. Results: A total of 2,037 patients with a variety of solid tumors from 16 trials were included for analysis. The overall incidence of all-grade skin rash was 88.2% (95% CI: 84.8–91.0%), with11.3% (95% CI: 8.8–14.3%) being high-grade (grade 3 or above). The overall incidence of all-grade acne-like skin rash was 81.6% (95% CI: 75.4–86.6%) with 6.5% (95% CI: 4.1–10.0%) being high-grade. Notably, patients with CRC exhibited a significantly higher incidence of high-grade skin rash (12.6%, 95% CI: 9.7–16.4%) than those with non-CRC (6.6%, 95% CI: 3.6–11.8%) with a risk ratio of 1.9 (95% CI: 1.0–3.6, p = 0.049). From randomized controlled studies, patients who received cetuximab had a significantly increased risk of developing high-grade skin rash in comparison with controls (RR 21.8, 95% CI: 6.9–68.8, p < 0.001). Conclusion: Cancer patients who received cetuximab have a substantial risk of developing high-grade skin rash. The risk may be particularly increased in patients with CRC. Further studies are strongly recommended for the prevention and treatment of high-grade skin rash.

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“…The largest two hepatic tumors had maximum diameters of 134.0 and 141.8 mm. After sigmoidectomy to resolve the obstruction, SOX (TS-1 and oxaliplatin) combined with panitumumab was initiated for RAS wild-type metastatic colon cancer ( Figure 1 , Hiromichi Maeda 2) , Satoshi Morita 3) , Tsuyoshi Sano 4) , Shunichiro Komatsu 4) , Takashi Arikawa 4) , Seiji Ishiguro 4) , Junichi Sakamoto 5) , Hideyuki Mishima 1) weeks. After four cycles of treatment, CT revealed a partial response of the tumor, with the maximum diameters of the two largest tumors shrinking to 98.9 and 84.2 mm, respectively.…”

Section: Case Onementioning

confidence: 99%

“…However, even in the case of 'RAS wild-type' tumors, tumor shrinkage by anti-EGFR antibody treatment is not guaranteed 2,3) . For example, first-line cetuximab monotherapy in patients with wild-type Kirsten rat sarcoma viral oncogene homologue (KRAS) mCRC is associated with only a 10% response rate, with a disease control rate of 44% 4) . Thus, most patients experience treatmentrelated adverse events, such as acneiform eruption, paronychia, and xerosis cutis, without any actual benefits of treatment 5) .…”

Section: Introductionmentioning

confidence: 99%

Early drop in serum lactate dehydrogenase concentrations as a predictor of tumor response to ongoing anti-epidermal growth factor receptor antibody treatment

Iwamoto¹,

Maeda²,

Morita³

et al. 2017

Ann. Cancer Res. Therap.

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Prediction of tumor responses before and during treatment for unresectable advanced and/or metastatic colorectal cancer is important to maximize treatment benefit to individual patients. In the present case series, we introduce the potential of using serum lactase dehydrogenase (LDH) concentrations to predict the tumor responses during treatment with anti-epidermal growth factor receptor antibody. Based on our observations, an early drop in serum LDH concentrations predicts tumor shrinkage, whereas maintenance of LDH concentrations presages a moderate response to treatment or tumor progression.

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First-line single-agent cetuximab in patients with advanced colorectal cancer

Cited by 41 publications

References 20 publications

Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial

Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial

Risk of High-Grade Skin Rash in Cancer Patients Treated with Cetuximab – an Antibody against Epidermal Growth Factor Receptor: Systemic Review and Meta-Analysis

Early drop in serum lactate dehydrogenase concentrations as a predictor of tumor response to ongoing anti-epidermal growth factor receptor antibody treatment

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