Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study

PFS is defined as the time interval measured from the day of first ivosidenib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.

OS is defined as the time interval measured from the day of first ivosidenib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.

TTF is defined as the time interval measured from the day of first ivosidenib until discontinuation of treatment for any reason including progression, toxicity, start of a new antineoplastic therapy, or death, whichever occurs first. Patients dropping out without knowledge of a potential ending of therapy (e.g., lost to follow up) will be censored with the last date of contact.

ORR is defined as the proportion of patients achieving a complete or partial response as best response. Patients without response measurement are considered non-responders.

DCR is defined as the proportion of patients achieving complete response, partial response, or stable disease as best response. Patients without response measurement are considered non-responders.

The case- and patient-based incidence of (S)AEs will be provided.

The case- and patient-based incidence of (S)ADRs will be provided.

The case- and patient-based incidence of AESIs will be provided.

The change from baseline (i.e., difference) in the scales of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer quality of life questionnaire C30) will be displayed for each point in time, using boxplots.

The scales of the EORTC QLQ-C30 range in score from 0 to 100. A high scale score represents a higher response level.

The change from baseline (i.e., difference) in the scales of the EORTC QLQ-BIL21 (European Organisation for Research and Treatment of Cancer quality of life questionnaire BIL21) will be displayed for each point in time, using boxplots.

The scales of the EORTC QLQ-BIL21 range in score from 0 to 100. A high scale score represents a higher response level.

Frequencies of distinct impact ratings for parameters affecting ivosidenib therapy choice will be visualized using stacked bar charts.

Frequencies of distinct satisfaction levels with ivosidenib treatment effectiveness and AE management will be visualized using stacked bar charts.

Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.

Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.

Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.

Frequency of dose modifications will be presented.

Type of dose modifications (i.e., dose reductions, dose escalations, and interruptions) will be presented.

Reasons for dose modifications will be presented.

Duration of treatment with ivosidenib

Reasons for end of treatment will be displayed

Type of substances given in the last previous therapy will be displayed.

Frequency of different substances given in the last previous therapy will be displayed.

Duration of last previous therapy line will be displayed.

Frequency of concomitant medications in total will be displayed.

Frequency of concomitant medications known to induce QT prolongation (e.g., antiarrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) will be displayed.

Frequency and type of subsequent antineoplastic therapies by line of therapy will be displayed.