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Chapter 67: Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules

Anton Wellstein; Giuseppe Giaccone; Michael B. Atkins; Edward A. Sausville

INTRODUCTION

A Note on Treatment Regimens

Cancer treatment regimens change to reflect continuous advances in basic and clinical science: new drugs, both small molecules and biologicals; improved methods of targeting and timing of drug delivery; agents with altered pharmacokinetic properties and selectivities; the use of rational multidrug combinations; and greater knowledge of the basic cell biology of tumorigenesis, metastasis, and immune function, amongst other advances. As a consequence, this chapter presents relatively few detailed treatment regimens; rather, we refer the reader to the web-based resources of the U.S. FDA and the NCCN. Table 67–1 provides two examples of therapeutic regimens that illustrate the complexity of current cancer drug therapy.

Table 67–1Cancer Treatment Regimens: Complexities and Resources
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Table 67–1 Cancer Treatment Regimens: Complexities and Resources

In treating cancers, the selection of the most appropriate treatment(s), dose, and dose intervals as well as the management of adverse effects requires specialized knowledge and a team effort. In addition, cancer treatment regimens are undergoing frequent updates due to findings in ongoing clinical trials. The availability of drugs with new mechanisms of action (e.g., immune checkpoint inhibitors), good target selectivity (e.g., kinase inhibitors), efficacy in specific cancers, and different adverse effect profiles permits the use of new drug combinations and regimens. The chapters on the pharmacotherapy of cancer focus on mechanism of action, ADME, and adverse effects, with less emphasis on treatment regimens. There are several excellent sources of up-to-date treatment information. The U.S. FDA provides authoritative information on approved drugs online (http://www.accessdata.fda.gov/scripts/cder/daf/. Detailed treatment guidelines for most cancers are available from the NCCN, an alliance of cancer centers that establishes evidence-based guidelines for cancer treatment. The NCCN guidelines are continuously updated to reflect new information that may alter clinical practice. The guidelines can be accessed online (https://www.nccn.org/professionals/physician_gls/f_guidelines.asp).

This table provides examples that illustrate the complexities of current treatment for two cancers: HER2+ breast cancer and advanced colorectal cancer.
SAMPLE TREATMENT REGIMENS
SUMMARY DRUGS, SCHEDULE, AND DOSING
HER2-Positive Breast Cancer  
Doxorubicin and cyclophosphamide (= AC) followed by paclitaxel, trastuzumab, and pertuzumab

Day 1: Doxorubicin 60 mg/m2 IV

Day 1: Cyclophosphamide 600 mg/m2 IV

Repeat cycle every 21 days for 4 cycles

 

Followed by

 

Day 1: Pertuzumab 840 mg IV followed by 420 mg IV

Day 1: Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV

Days 1, 8, and 15: Paclitaxel 80 mg/m2 IV

Repeat cycle every 21 days for 4 cycles

Day 1: Trastuzumab 6 mg/kg IV

Repeat cycle every 21 days to complete 1 year of trastuzumab therapy

 

Cardiac monitoring at baseline and 3-month intervals
Advanced or Metastatic Colorectal Cancer RAS wild-type
Oxaliplatin, leucovorin, 5FU (= FOLFOX) plus cetuximab

Day 1: Oxaliplatin 85 mg/m2 IV over 2 h

Day 1: Leucovorin 400 mg/m2 IV over 2 h

Days 1–3: 5FU 400 mg/m2 IV bolus on day 1, ...

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