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Reports of the Demise of Chemotherapy Have Been Greatly Exaggerated
Bruce Feinberg, DO; Jonathan Kish, PhD, MPH; Igoni Dokubo, MD; Jeff Wojtynek, PharmD; and Kevin Lord, PhD, MHS
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Reports of the Demise of Chemotherapy Have Been Greatly Exaggerated

Bruce Feinberg, DO; Jonathan Kish, PhD, MPH; Igoni Dokubo, MD; Jeff Wojtynek, PharmD; and Kevin Lord, PhD, MHS
The expanding arsenal of targeted and immuno-oncology drugs has unalterably changed the landscape of systemic cancer treatment, but chemotherapy will remain critical for years if not decades to come.
Chemotherapy Over the Next 5 Years

Expedited drug approval processes (eg, Accelerated Approval Program, cohort expansion trial design, tumor-agnostic mutational drug indications), in conjunction with policy initiatives, are revolutionizing drug development. What had been a historical benchmark of 12 years to navigate phase 1 to 3 trial completion and FDA approval has, in recent years, been slashed to half that duration. What does this rapid pace of change herald for traditional cytotoxic chemotherapy? A review of BC trials in progress may shed some light. A ClinicalTrials.gov search of all actively recruiting US clinical trials of pharmacologic interventions in mBC was conducted on September 20, 2018. There were 311 identified trials: 146 included a chemotherapy component, with 91 including chemotherapy in combination with a novel agent. In comparison, 27 studies were of CDK 4/6 inhibitor therapy without chemotherapy. Phase 3 studies consisted of 18 evaluating CDK 4/6 inhibitors, 13 evaluating chemotherapy in combination with a novel agent, and 7 comparing chemotherapy with a novel agent. A similar search of phase 3 trials of actively accruing adjuvant BC trials found 26 studies: 15 involving chemotherapy, with 8 using chemotherapy in the experimental arm, both alone and in combination with targeted and immunologic drugs. The extent to which chemotherapy remains a component of mBC research leaves little doubt as to its critical role for years to come.

Conclusions

The development of precision medicine approaches in the treatment of advanced malignancy has dramatically altered the management and outcomes of patients with cancer. Despite the rapid advances of science and improved regulatory processes that are allowing those advances to move from bench to bedside in as little as 3 to 5 years, chemotherapy remains a critical component of solid tumor and hematologic malignancy treatment today and likely for years to come. We chose to illustrate this with an exploration of the development of systemic therapies for BC, given its history as a field that has heralded many of the hallmarks of modern cancer treatment. A similar case could have been made for researching treatments of many of the most common and lethal cancers: colorectal, ovarian, and even lung. Although effective, the current arsenal of chemotherapeutic interventions presents its own particular set of patient-centric challenges due to the agents’ impact on quality of life, their limited efficacy, and their significant adverse effects. However, despite this and the explosion in targeted and immunologic therapy approvals, as well as the ongoing research that will likely extend their number and indications, research on traditional systemic cytotoxic drugs should not be abandoned. The end of the chemotherapy era is not near; chemotherapy will play a significant role in the treatment of mBC, among a host of other common cancers, in the years if not decades to come. Further research is warranted to understand the comparative effectiveness of the currently approved chemotherapeutic agents and to explore new agents with greater patient-centricity.

Acknowledgments

This work was funded by Athenex, Inc. Cardinal Health conducted the literature review and drafted the manuscript content. Athenex provided editorial review.

Author Affiliations: Cardinal Health Specialty Solutions (BF, JK, KL), Dublin, OH; Athenex, Inc (ID, JW), Buffalo, NY.

Source of Funding: Athenex, Inc.

Author Disclosures: Dr Kish reports employment with and stock ownership in Cardinal Health. Drs Dokubo and Wojtynek report employment with and stock ownership in Athenex, Inc. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (BF, JK, ID, JW, KL); acquisition of data (BF, JK, KL); analysis and interpretation of data (BF, JK, KL); drafting of the manuscript (BF, JK, ID, KL); critical revision of the manuscript for important intellectual content (BF, JK, ID, JW, KL); obtaining funding (ID); administrative, technical, or logistic support (BF, JW); and supervision (JK, JW).

Address Correspondence to: Kevin Lord, PhD, MHS, Cardinal Health Specialty Solutions, 7000 Cardinal Pl, Dublin, OH 43017. Email: kevin.lord@cardinalhealth.com.
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