Dirk Arnold, MD, director, Department of Medical Oncology at Klinik für Tumorbiologie, Freiburg, Germany, discusses the phase IIIb CONSIGN study, which looked at treatment with regorafenib for previously treated patients with metastatic colorectal cancer (mCRC).

The CONSIGN trial reported on 2,872 patients from more than 180 institutions; it is a truly worldwide initiative, said Arnold. In this "real world" experience, the median treatment duration with regorafenib was 2.5 months. Patients received a median of 3 cycles of regorafenib (range, 1—33) at a median daily dose of 160mg (range, 74–166).

The trial was a follow-up to the phase III CORRECT trial, which demonstrated a median progression-free survival (PFS) of 2.0 months with regorafenib compared with 1.7 months with placebo (HR, 0.49; 95% CI, 0.42-0.58; 

 <.0001). Based on findings from this study, the FDA approved regorafenib in September 2012. 

The CONSIGN trial confirmed the results of the CORRECT trial, demonstrating a median PFS of 2.7 months (95% CI, 2.6-2.7). Adverse events were also similar between the two studies. Overall, 87% of patients required dose modifications, with 46% experiencing an adverse event that required a dose reduction.

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Dirk Arnold, MD, Director Department of Medical Oncology at Klinik fÃ¼r Tumorbiologie, Freiburg, Germany, Arnold Discusses the CONSIGN Study.


Dr. Dirk Arnold Discusses the CONSIGN Study

Dirk Arnold, MD, director of the Department of Medical Oncology at Klinik für Tumorbiologie, Freiburg, Germany, discusses the phase III Sirflox study, which looked at selective internal radiation therapy (SIRT) using Yttrium-90 (Y-90) resin microspheres for the treatment of metastatic colorectal cancer.

The trial included 530 randomized patients, half that received standard chemotherapy, which is FOLFOX6 with or without bevacizumab. The other half received Y-90 SIRT, which was given after the first or second administration of FOLFOX6 with or without bevacizumab. This treatment is for the palliative patient, said Arnold.

The results were surprising, said Arnold. There was no improvement in progression-free survival when all patients were taken into consideration. However, progression of the liver was significantly reduced with SIRT. This may be because many of the patients in the trial had disease in more than just the liver, which was not effected by the SIRT, said Arnold.

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 Dirk Arnold, MD, director of the Department of Medical Oncology at Klinik fÃ¼r Tumorbiologie, Freiburg, Germany, discusses the phase III Sirflox study, which looked at selective internal radiation therapy (SIRT) using Yttrium-90 (Y-90) resin microspheres for the treatment of metastatic colorectal cancer.

Dr. Dirk Arnold on Sirflox Study Results in Colorectal Cancer

Dirk Arnold, MD, director, Department of Medical Oncology, Tumour Biology Centre, Freiburg, Germany, discusses a phase III trial looking at options for maintenance therapy for metastatic colorectal cancer (mCRC). This study was presented at the ESMO 16th World Congress on Gastrointestinal Cancer.

There is currently some uncertainty as to how to use maintenance therapy after standard induction chemotherapy. Patients on this trial were randomized to continue to receive fluoropyrimidine and bevacizumab, bevcizumab alone, or to discontinue treatment.

When considering re-induction, Arnold says, bevacizumab alone as maintenance was not inferior to standard 5FU plus bevacizumab. Discontinuing treatment was inferior.

When considering time from randomization to first progression, the best option was 5FU plus bevacizumab, followed by bevacizumab alone. Discontinued treatment was the worst option, Arnold says.

Researchers concluded that maintenance therapy with any fluoropyrimidine and bevacizumab should be continued until first progression.

Dirk Arnold, MD, director, Department of Medical Oncology, Tumour Biology Centre, Freiburg, Germany, discusses a phase III trial looking at options for maintenance therapy for metastatic colorectal cancer (mCRC).

Dr. Arnold on a Phase III Trial Examining Options for Maintenance Therapy in mCRC

Dirk Arnold, MD, director of the University Cancer Center Hamburg at the University Medical Center Hamburg-Eppendorf, in Germany, discusses results of a phase III randomized trial that continued bevacizumab (Avastin) plus standard chemotherapy into the second-line for patients with metastatic colorectal cancer (mCRC).

The trial enrolled 820 patients with mCRC who had progressed after receiving bevacizumab plus an oxaliplatin- or irinotecan-based chemotherapy. For a second-line therapy, patients on the trial were randomized to continue bevacizumab in combination with the opposite chemotherapy or chemotherapy alone.

The trial found a median overall survival of 11.2 months for the combination arm compared to 9.8 months for those receiving chemotherapy alone (HR = 0.81). Additionally, Arnold notes the continuation of bevacizumab did not result in additional toxicity.

Dr. Dirk Arnold, from the University Cancer Center Hamburg, Germany, on Second-Line Bevacizumab Continuation Therapy for Metastatic Colorectal Cancer

Dirk Arnold, MD

Articles

Dr. Dirk Arnold Discusses the CONSIGN Study

Dr. Dirk Arnold on Sirflox Study Results in Colorectal Cancer

Dr. Arnold on a Phase III Trial Examining Options for Maintenance Therapy in mCRC

Dr. Arnold on Second-Line Avastin Continuation for mCRC