Prospective multicenter study of the impact of Oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients

Geetika Srivastava, Lindsay A. Renfro, Robert J. Behrens, Margarita Lopatin, Calvin Chao, Gamini S. Soori, Shaker R. Dakhil, Rex B. Mowat, J. Philip Kuebler, George Kim, Miroslaw Mazurczak, Mark Lee, Steven Robert Alberts

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Purpose.The Oncotype DX colon cancer assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. This prospective study evaluated the impact of recurrence score (RS) results on physician recommendations regarding adjuvant chemotherapy in T3, mismatch repair-proficient (MMR-P) stage II colon cancer patients. Patients and Methods. Stage IIA colon cancer patients were enrolled in 17 centers. Patient tumor specimens were assessed by the RS test (quantitative reverse transcription-polymerase chain reaction) and mismatch repair (immuno-histochemistry). For each patient, the physician's recommended postoperative treatment plan of observation, fluoropyrimidine monotherapy, or combination therapy with oxaliplatin was recorded before and after the RS and mismatch repair results were provided. Results. Of 221 enrolled patients, 141 patients had T3 MMR-P tumors and were eligible for the primary analysis. Treatment recommendations changed for 63 (45%; 95% confidence interval: 36%-53%) of these 141 T3 MMR-P patients, with intensity decreasing for 47 (33%) and increasing for 16 (11%). Recommendations for chemotherapy decreased from 73 patients (52%) to 42 (30%), following review of RS results by physician and patient. Increased treatment intensity was more often observed at higher RS values, and decreased intensity was observed at lower values (p =.011). Conclusion. Compared with traditional clinicopathological assessment, incorporation of the RS result into clinical decision making was associated with treatment recommendation changes for 45% of T3 MMR-P stage II colon cancer patients in this prospective multicenter study. Use of the RS assay may lead to overall reduction in adjuvant chemotherapy use in this subgroup of stage II colon cancer patients.

Original languageEnglish (US)
Pages (from-to)492-497
Number of pages6
JournalOncologist
Volume19
Issue number5
DOIs
StatePublished - 2014

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Colonic Neoplasms
Multicenter Studies
Prospective Studies
DNA Mismatch Repair
Recurrence
Therapeutics
oxaliplatin
Adjuvant Chemotherapy
Physicians
Reverse Transcription
Neoplasms
Observation
Confidence Intervals
Drug Therapy
Polymerase Chain Reaction

Keywords

  • Adjuvant
  • Chemotherapy
  • Colon cancer
  • Decision analysis
  • Risk assessment

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Prospective multicenter study of the impact of Oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients. / Srivastava, Geetika; Renfro, Lindsay A.; Behrens, Robert J.; Lopatin, Margarita; Chao, Calvin; Soori, Gamini S.; Dakhil, Shaker R.; Mowat, Rex B.; Philip Kuebler, J.; Kim, George; Mazurczak, Miroslaw; Lee, Mark; Alberts, Steven Robert.

In: Oncologist, Vol. 19, No. 5, 2014, p. 492-497.

Research output: Contribution to journalArticle

Srivastava, G, Renfro, LA, Behrens, RJ, Lopatin, M, Chao, C, Soori, GS, Dakhil, SR, Mowat, RB, Philip Kuebler, J, Kim, G, Mazurczak, M, Lee, M & Alberts, SR 2014, 'Prospective multicenter study of the impact of Oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients', Oncologist, vol. 19, no. 5, pp. 492-497. https://doi.org/10.1634/theoncologist.2013-0401
Srivastava, Geetika ; Renfro, Lindsay A. ; Behrens, Robert J. ; Lopatin, Margarita ; Chao, Calvin ; Soori, Gamini S. ; Dakhil, Shaker R. ; Mowat, Rex B. ; Philip Kuebler, J. ; Kim, George ; Mazurczak, Miroslaw ; Lee, Mark ; Alberts, Steven Robert. / Prospective multicenter study of the impact of Oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients. In: Oncologist. 2014 ; Vol. 19, No. 5. pp. 492-497.
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abstract = "Purpose.The Oncotype DX colon cancer assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. This prospective study evaluated the impact of recurrence score (RS) results on physician recommendations regarding adjuvant chemotherapy in T3, mismatch repair-proficient (MMR-P) stage II colon cancer patients. Patients and Methods. Stage IIA colon cancer patients were enrolled in 17 centers. Patient tumor specimens were assessed by the RS test (quantitative reverse transcription-polymerase chain reaction) and mismatch repair (immuno-histochemistry). For each patient, the physician's recommended postoperative treatment plan of observation, fluoropyrimidine monotherapy, or combination therapy with oxaliplatin was recorded before and after the RS and mismatch repair results were provided. Results. Of 221 enrolled patients, 141 patients had T3 MMR-P tumors and were eligible for the primary analysis. Treatment recommendations changed for 63 (45{\%}; 95{\%} confidence interval: 36{\%}-53{\%}) of these 141 T3 MMR-P patients, with intensity decreasing for 47 (33{\%}) and increasing for 16 (11{\%}). Recommendations for chemotherapy decreased from 73 patients (52{\%}) to 42 (30{\%}), following review of RS results by physician and patient. Increased treatment intensity was more often observed at higher RS values, and decreased intensity was observed at lower values (p =.011). Conclusion. Compared with traditional clinicopathological assessment, incorporation of the RS result into clinical decision making was associated with treatment recommendation changes for 45{\%} of T3 MMR-P stage II colon cancer patients in this prospective multicenter study. Use of the RS assay may lead to overall reduction in adjuvant chemotherapy use in this subgroup of stage II colon cancer patients.",
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T1 - Prospective multicenter study of the impact of Oncotype DX colon cancer assay results on treatment recommendations in stage II colon cancer patients

AU - Srivastava, Geetika

AU - Renfro, Lindsay A.

AU - Behrens, Robert J.

AU - Lopatin, Margarita

AU - Chao, Calvin

AU - Soori, Gamini S.

AU - Dakhil, Shaker R.

AU - Mowat, Rex B.

AU - Philip Kuebler, J.

AU - Kim, George

AU - Mazurczak, Miroslaw

AU - Lee, Mark

AU - Alberts, Steven Robert

PY - 2014

Y1 - 2014

N2 - Purpose.The Oncotype DX colon cancer assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. This prospective study evaluated the impact of recurrence score (RS) results on physician recommendations regarding adjuvant chemotherapy in T3, mismatch repair-proficient (MMR-P) stage II colon cancer patients. Patients and Methods. Stage IIA colon cancer patients were enrolled in 17 centers. Patient tumor specimens were assessed by the RS test (quantitative reverse transcription-polymerase chain reaction) and mismatch repair (immuno-histochemistry). For each patient, the physician's recommended postoperative treatment plan of observation, fluoropyrimidine monotherapy, or combination therapy with oxaliplatin was recorded before and after the RS and mismatch repair results were provided. Results. Of 221 enrolled patients, 141 patients had T3 MMR-P tumors and were eligible for the primary analysis. Treatment recommendations changed for 63 (45%; 95% confidence interval: 36%-53%) of these 141 T3 MMR-P patients, with intensity decreasing for 47 (33%) and increasing for 16 (11%). Recommendations for chemotherapy decreased from 73 patients (52%) to 42 (30%), following review of RS results by physician and patient. Increased treatment intensity was more often observed at higher RS values, and decreased intensity was observed at lower values (p =.011). Conclusion. Compared with traditional clinicopathological assessment, incorporation of the RS result into clinical decision making was associated with treatment recommendation changes for 45% of T3 MMR-P stage II colon cancer patients in this prospective multicenter study. Use of the RS assay may lead to overall reduction in adjuvant chemotherapy use in this subgroup of stage II colon cancer patients.

AB - Purpose.The Oncotype DX colon cancer assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. This prospective study evaluated the impact of recurrence score (RS) results on physician recommendations regarding adjuvant chemotherapy in T3, mismatch repair-proficient (MMR-P) stage II colon cancer patients. Patients and Methods. Stage IIA colon cancer patients were enrolled in 17 centers. Patient tumor specimens were assessed by the RS test (quantitative reverse transcription-polymerase chain reaction) and mismatch repair (immuno-histochemistry). For each patient, the physician's recommended postoperative treatment plan of observation, fluoropyrimidine monotherapy, or combination therapy with oxaliplatin was recorded before and after the RS and mismatch repair results were provided. Results. Of 221 enrolled patients, 141 patients had T3 MMR-P tumors and were eligible for the primary analysis. Treatment recommendations changed for 63 (45%; 95% confidence interval: 36%-53%) of these 141 T3 MMR-P patients, with intensity decreasing for 47 (33%) and increasing for 16 (11%). Recommendations for chemotherapy decreased from 73 patients (52%) to 42 (30%), following review of RS results by physician and patient. Increased treatment intensity was more often observed at higher RS values, and decreased intensity was observed at lower values (p =.011). Conclusion. Compared with traditional clinicopathological assessment, incorporation of the RS result into clinical decision making was associated with treatment recommendation changes for 45% of T3 MMR-P stage II colon cancer patients in this prospective multicenter study. Use of the RS assay may lead to overall reduction in adjuvant chemotherapy use in this subgroup of stage II colon cancer patients.

KW - Adjuvant

KW - Chemotherapy

KW - Colon cancer

KW - Decision analysis

KW - Risk assessment

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