Name that AE
These were the most common (3) adverse events in the CONKO-003 trial.
What is anemia, N/V, & pain?
The goal (purpose) of the CONKO-003 trial was this…
What is to assess the efficacy of 2nd-line oxaliplation č FF in patients with PDAC who had progressed on gemcitabine monotherapy?
These were the five inclusion criteria…
What are 1.) at least 18 years old, 2.) KPS of 70+, 3.) adequate renal function, 4.) adequate hepatic function, & 5.) adequate bone marrow function?
These drugs were included in the CONKO-003 trial.
What is oxaliplatin, folinic acid (LV), and fluorouracil?
A graphical method of displaying survival data or time-to-event analysis (i.e. the proportion of patents surviving against time) that is usually drawn as a step function.
What is a Kaplan-Meier curve?
The difference between overall survival rate and median overall survival rate is...
What is OS rate is the percentage of patients alive at a given point after treatment (5-yr survival) vs median overall survival being the length of time after diagnosis/treatment that half of the patients are still alive?
These were the most commonly reported (3) non-hematologic AEs:
What is N/V, diarrhea, and sensory neuropathy?
The CONKO-003 was this type of study (phase, placebo-controlled, etc…
What is phase III, RANDOMIZED, open-label?
These were the three exclusion criteria:
What is 1.) concomitant disease that would compromise safety, 2.) intractable pain, and 3.) hypersensitivity to any of the study drugs?
The regimen (drug doses & frequency) for the FF arm of the trial was this.
What is folinic acid IV 200mg/m2 followed by fluorouracil 2000mg/m2 CIV over 24 hours on days 1,8,15,&22 followed by a three week rest period (days 23-42)?
This is a measure of an effect of an intervention on an outcome of interest over time. It is most commonly reported in time-to-event analysis or survival analysis (i.e. when we are interested in knowing how long it takes for a particular event/outcome to occur).
What is Hazard Ratio?
The difference between baseline characteristics and eligibility criteria is…
What is baseline characteristics are data (demographics) collected at the beginning of the trial such age, gender, race, ethnicity, & specific study measures vs eligibility criteria are criteria the study patients must meet (KPS, blood counts, renal function, etc)?
Most hematologic and non-hematologic AEs were grades…
What is 1 & 2?
This many patients were included in the study and assigned to each arm?
168 were randomized and 8 were excluded after randomization. Of the 160 remaining, 76 were assigned to the OFF arm and 84 were assigned to the FF arm.
In the trial, overall survival was defined as...
What is from the time of randomization until the last contact or death?
The regimen for the OFF arm was this.
What is oxaliplatin 85mg/m2 IV on days 8 & 22, and folinic acid IV 200mg/m2 followed by fluorouracil 2000mg/m2 CIV over 24 hours on days 1,8,15,&22 followed by a three week rest period (days 23-42)?
This type of analysis includes every subject who is randomized according to randomized treatment assignment and ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. Using this approach, the estimate of treatment effect is generally conservative.
What is Intention-to-treat analysis?
The primary difference in adverse events between the OFF arm and the FF arm is this.
What is parenthesia and leucopenia were significantly higher in the OFF arm? (INTERESTING TO NOTE: Grade 1 diarrhea was higher in the FF arm (15% vs 9% in the OFF arm)
The difference in neurotoxicity between the OFF & FF arms were this…
What is OFF- 29 pts (38%) vs FF- 6 pts (7%)?
The OS and PFS for each arm of the trial is this…
What is overall survival OFF- 5.9 months vs FF 3.3 months and PFS OFF- 2.9 months vs FF 2.0 months?
In the trial, disease progression was evaluated using...
What is CT/MRI every 2 months during the study to assess response (or more frequently if clinically indicated)?
A dose reduction of ____% was required in ____% of oxaliplatin administrations; ___% of oxaliplatin administrations were full doses.
What is 75%, 10%, & 81%?
In this study, the definition of PFS is this.
What is the PFS was not clearly defined in the CONKO-003 trial? Generally, PFS is defined as the time from randomization until progression or death?
The recruitment period for the CONKO-003 trial was this.
What is January 2004-May 2007?
This number of patients in the OFF group had grade 3 neuropathy?
What is 3?
The limitations of the study were this…
What is the CONKO-003 trial was performed before FOLFIRINOX & Gem/Nab-pac became 1st-line treatment options for PDAC. (IMPORTANT NOTE: However, use of either regimen in the 2nd-line setting has yet to be generated).
Patients were stratified into these categories.
What are KPS, duration of first-line therapy, and presence of metastasis?
In the trial, the range of oxaliplatin (maximum number of doses given) was this.
What is 340mg/m2 to 4080mg/m2 (4-48 doses)?
This should be taken into consideration when interpreting the statistical significance of a secondary endpoint, such as PFS and subgroup analysis.
What is the power of the study? (IMPORTANT NOTE: The CONKO-003 trial was powered to should statistical significance of OS but was not powered for secondary endpoints and subgroup analysis to be significant for interpretation).
The author’s of the CONKO-003 study concluded this.
What is that 2nd-line OFF significantly extended overall survival compared to FF in gem-refractory pancreatic cancer?
The word “CONKO” was coined from this.
What is one of the primary institutions supporting the study: Charité ONKOlogie?