Question

Twenty percent of patients in a study done at the MTD to determine the response to a new chemotherapeutic agent were found to have unacceptable toxicity. How can this occur when the MTD was determined in a well-conducted traditional dose escalation dose-finding study?

Answer 1

In a well-conducted traditional dose escalation dose-finding study, some patients may still experience unacceptable toxicity due to individual variations and rare toxicities.

Step-by-step explanation:

In a well-conducted traditional dose escalation dose-finding study, the maximum tolerated dose (MTD) of a new chemotherapeutic agent is determined. However, even in a well-conducted study, some patients may still experience unacceptable toxicity. This can occur due to several factors:

1. The MTD may not be suitable for all patients, as individual patients may have different tolerance levels for the drug.
2. There can be patient-specific factors such as genetic variations that make them more susceptible to toxicity.
3. The MTD may not accurately represent all possible toxicity profiles, as some rare or unexpected toxicities may only be observed after the drug is used in a larger population.

Overall, while a well-conducted study helps determine the general tolerance of a drug, individual variations and rare toxicities can still occur.