Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study

Fuchs, Charles S.; Marshall, John L.; Mitchell, Edith P.; Wierzbicki, Rafal; Ganju, Vinod; Jeffery, Mark; Schulz, Joseph J.; Richards, Donald A.; Soufi-Mahjoubi, Raoudha; Wang, Benjamin; Barrueco, José

doi:10.1200/jco.2007.11.3357

Cited by 712 publications

(497 citation statements)

References 18 publications

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“…[2][3][4] For the subgroup of patients with limited metastatic disease in the liver, nonrandomized studies have shown that patients who can undergo resection of liver metastases have 5-year survivals of 30% to 40%. [18][19][20] As a result, the integration of aggressive local therapy along with systemic treatment has been playing an increasingly important role in treatment for this disease.…”

Section: Discussionmentioning

confidence: 99%

Stereotactic body radiotherapy for colorectal liver metastases

Chang

Swaminath

Kozak

et al. 2011

Cancer

267

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BACKGROUND: This study was undertaken to determine outcomes of stereotactic body radiotherapy for colorectal liver metastases in a pooled patient cohort. METHODS: Patients with colorectal liver metastases from 3 institutions were included if they had 1 to 4 lesions, received 1 to 6 fractions of stereotactic body radiotherapy, and had radiologic imaging 3 months post-treatment. Sixty-five patients with 102 lesions treated from August 2003 to May 2009 were retrospectively analyzed. A tumor control probability (TCP) model was used to estimate the 3-fraction dose required for >90% local control after converting the schedule into biologically equivalent dose (BED), single-fraction equivalent dose, or linear quadratic model-based single-fraction dose. RESULTS: Forty-seven (72%) patients had 1 chemotherapy regimen before stereotactic body radiotherapy, and 27 (42%) patients had 2 regimens. The median followup was 1.2 years (range, 0.3-5.2 years). The median dose was 42 gray (Gy; range, 22-60 Gy). When evaluated separately by multivariate analysis, total dose (P ¼ .0015), dose/fraction (P ¼ .003), and BED (P ¼ .004) all correlated with local control by lesion. On multivariate analysis, nonactive extrahepatic disease was associated with overall survival (OS; P ¼ .046), and sustained local control was closely correlated (P ¼ .06). By using single-fraction equivalent dose, BED, or linear quadratic model-based single-fraction dose in the TCP model, the estimated dose range needed for 1-year local control >90% is 46 to 52 Gy in 3 fractions. CONCLUSIONS: Liver stereotactic body radiotherapy is well tolerated and effective for colorectal liver metastases. The strong correlation between local control and OS supports controlling hepatic disease even for heavily pretreated patients. For a 3-fraction regimen of stereotactic body radiotherapy, a prescription dose of 48 Gy should be considered, if normal tissue constraints allow. Cancer 2011;117:4060-

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Section: Discussionmentioning

confidence: 99%

Stereotactic body radiotherapy for colorectal liver metastases

Chang

Swaminath

Kozak

et al. 2011

Cancer

267

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“…Scheithauer et al 182 Cochrane Database 183 Saltz et al 120 and de Gramont et al 131 Goldberg et al 135 and Fuchs et al 121 Hurwitz et al 146 Tumor invades submucosa T 2 Tumor invades muscularis propia T 3 Tumor invades through the muscularis propria into the subserosa T 4 Tumor directly invades other organs or structures, or perforates visceral Peritoneum Regional lymph nodes (N) N x…”

Section: Adapted With Permission From Meyerhardt and Mayer 31mentioning

confidence: 99%

Systemic Treatment of Colorectal Cancer

2008

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Colorectal cancer is the fourth most common non-cutaneous malignancy in the United States and the second most frequent cause of cancer-related death. Over the past 12 years, significant progress has been made in the systemic treatment of this malignant condition. Six new chemotherapeutic agents have been introduced, increasing median overall survival for patients with metastatic colorectal cancer from less than 9 months with no treatment to approximately 24 months. For patients with stage III (lymph node positive) colon cancer, an overall survival benefit for fluorouracil-based chemotherapy has been firmly established, and recent data have shown further efficacy for the inclusion of oxaliplatin in such adjuvant treatment programs. For patients with stage II colon cancer, the use of adjuvant chemotherapy remains controversial, but may be appropriate in a subset of individuals at higher risk for disease recurrence. Ongoing randomized clinical trials are evaluating how best to combine currently available therapies, while smaller studies are evaluating new agents, with the goal of continued progress in prolonging life among patients with metastatic colorectal cancer and increasing cure rates among those with resectable disease.

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“…The combination of capecitabine with irinotecan (XELIRI) plus Bev resulted in a disease control rate of 72-82% and median PFS of 9-12 months (Reinacher-Schick et al, 2008;Renouf et al, 2012;Pectasides et al, 2012;Ducreux et al, 2013). On the other hand, earlier trials evaluating chemotherapy regimen with capecitabine and irinotecan had showed that CAPIRI regimen was associated with unacceptable incidences of severe gastrointestinal adverse effects with grade 3-4 diarrhea up to 36% of patients (Rothenberg et al, 2001;Fuchs et al, 2007;Koopman et al, 2007). In the randomized phase II trial performed by Fuchs et al (BICC-C), three regimens were evaluated (FOLFIRI, modified IFL or CAPIRI) and the authors were obtained median PFS times 7.6 months for FOLFIRI, 5.9 months for mIFL and 5.8 months for CAPIRI, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Because of toxicity, further enrollment onto CAPIRI was discontinued. After the amendment to add Bev, the authors achieved the median OS interval for 19.2 months for mIFL-Bev, while it has not been reached for FOLFIRI-Bev (Fuchs et al, 2007). In a retrospective study of Ocvirk et al (2011) the authors reported that no DOI:http://dx.doi.org/10.7314/APJCP.2013.14.4.2283 significant differences were observed between patients treated with XELIRI or FOLFIRI in combination with Bev with respect to PFS, OS and oRR.…”

Section: Discussionmentioning

confidence: 99%