A phase II study of preoperative mFOLFOX6 with short-course radiotherapy in patients with locally advanced rectal cancer and liver-only metastasis

Kyung Hwan Kim, Sang Joon Shin, Min Soo Cho, Joong Bae Ahn, Minkyu Jung, Tae Il Kim, Young Suk Park, Hoguen Kim, Namkyu Kim, Woong Sub Koom

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13 Citations (Scopus)

Abstract

Background and purpose To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases. Materials and methods This single-arm phase II study involved 32 patients. mFOLFOX6 was administered for four cycles followed by SCRT and another four cycles of mFOLFOX6. Surgery was performed 4-6 weeks after the last chemotherapy cycle. The primary endpoint was complete (R0) resection rate. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), and complication rates. Results Surgical resection of the rectum and liver was performed in 25 patients (78%) and R0 resection was achieved in 20 patients (63%). Local tumor downstaging was observed in 54% of patients. Median OS and PFS were 38 and 9 months, respectively. One patient discontinued treatment due to toxicity and no treatment-related deaths occurred. Patients who progressed after 4 cycles of mFOLFOX6 were less likely to receive resection. Conclusions This regimen was safe and effective in inducing local tumor response and achieving R0 resection in this patient population.

Original languageEnglish
Pages (from-to)369-374
Number of pages6
JournalRadiotherapy and Oncology
Volume118
Issue number2
DOIs
Publication statusPublished - 2016 Feb 1

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Liver Neoplasms
Rectal Neoplasms
Radiotherapy
Neoplasm Metastasis
Disease-Free Survival
Rectum
Neoplasms
Survival Rate
Safety
Drug Therapy
Survival
Liver
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Kim, Kyung Hwan ; Shin, Sang Joon ; Cho, Min Soo ; Ahn, Joong Bae ; Jung, Minkyu ; Kim, Tae Il ; Park, Young Suk ; Kim, Hoguen ; Kim, Namkyu ; Koom, Woong Sub. / A phase II study of preoperative mFOLFOX6 with short-course radiotherapy in patients with locally advanced rectal cancer and liver-only metastasis. In: Radiotherapy and Oncology. 2016 ; Vol. 118, No. 2. pp. 369-374.
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abstract = "Background and purpose To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases. Materials and methods This single-arm phase II study involved 32 patients. mFOLFOX6 was administered for four cycles followed by SCRT and another four cycles of mFOLFOX6. Surgery was performed 4-6 weeks after the last chemotherapy cycle. The primary endpoint was complete (R0) resection rate. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), and complication rates. Results Surgical resection of the rectum and liver was performed in 25 patients (78{\%}) and R0 resection was achieved in 20 patients (63{\%}). Local tumor downstaging was observed in 54{\%} of patients. Median OS and PFS were 38 and 9 months, respectively. One patient discontinued treatment due to toxicity and no treatment-related deaths occurred. Patients who progressed after 4 cycles of mFOLFOX6 were less likely to receive resection. Conclusions This regimen was safe and effective in inducing local tumor response and achieving R0 resection in this patient population.",
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A phase II study of preoperative mFOLFOX6 with short-course radiotherapy in patients with locally advanced rectal cancer and liver-only metastasis. / Kim, Kyung Hwan; Shin, Sang Joon; Cho, Min Soo; Ahn, Joong Bae; Jung, Minkyu; Kim, Tae Il; Park, Young Suk; Kim, Hoguen; Kim, Namkyu; Koom, Woong Sub.

In: Radiotherapy and Oncology, Vol. 118, No. 2, 01.02.2016, p. 369-374.

Research output: Contribution to journalArticle

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T1 - A phase II study of preoperative mFOLFOX6 with short-course radiotherapy in patients with locally advanced rectal cancer and liver-only metastasis

AU - Kim, Kyung Hwan

AU - Shin, Sang Joon

AU - Cho, Min Soo

AU - Ahn, Joong Bae

AU - Jung, Minkyu

AU - Kim, Tae Il

AU - Park, Young Suk

AU - Kim, Hoguen

AU - Kim, Namkyu

AU - Koom, Woong Sub

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N2 - Background and purpose To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases. Materials and methods This single-arm phase II study involved 32 patients. mFOLFOX6 was administered for four cycles followed by SCRT and another four cycles of mFOLFOX6. Surgery was performed 4-6 weeks after the last chemotherapy cycle. The primary endpoint was complete (R0) resection rate. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), and complication rates. Results Surgical resection of the rectum and liver was performed in 25 patients (78%) and R0 resection was achieved in 20 patients (63%). Local tumor downstaging was observed in 54% of patients. Median OS and PFS were 38 and 9 months, respectively. One patient discontinued treatment due to toxicity and no treatment-related deaths occurred. Patients who progressed after 4 cycles of mFOLFOX6 were less likely to receive resection. Conclusions This regimen was safe and effective in inducing local tumor response and achieving R0 resection in this patient population.

AB - Background and purpose To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases. Materials and methods This single-arm phase II study involved 32 patients. mFOLFOX6 was administered for four cycles followed by SCRT and another four cycles of mFOLFOX6. Surgery was performed 4-6 weeks after the last chemotherapy cycle. The primary endpoint was complete (R0) resection rate. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), and complication rates. Results Surgical resection of the rectum and liver was performed in 25 patients (78%) and R0 resection was achieved in 20 patients (63%). Local tumor downstaging was observed in 54% of patients. Median OS and PFS were 38 and 9 months, respectively. One patient discontinued treatment due to toxicity and no treatment-related deaths occurred. Patients who progressed after 4 cycles of mFOLFOX6 were less likely to receive resection. Conclusions This regimen was safe and effective in inducing local tumor response and achieving R0 resection in this patient population.

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