Sergio Cifuentes, Cancer Research Project Manager at CENEIT México, posted on X:

“Critiques on the PLATFORM study design
(Cape-Ram maintenance after 1L chemo in advanced esophagogastric adenocarcinoma)

1. Phase II, low power
Only 47 patients randomized. Limited statistical power undermines OS analysis and toxicity data robustness. Exploratory, not practice-changing.

2. Early arm closure
Sponsor withdrawal led to premature termination of the cape-ram arm, introducing potential selection bias and affecting study validity.

3. Suboptimal control: surveillance
Control arm was observation, not active treatment. This may inflate cape-ram efficacy vs. an inactive comparator. Not reflective of clinical practice.

4. Obsolete vs. current standard
By design time, CM649 had already shown benefit of chemo+IO followed by IO maintenance. PLATFORM excluded IO entirely—limits its relevance today.

5. Notable toxicity
Grade ≥3 AEs occurred in 57% of cape-ram vs. 32% surveillance. The toxicity burden is significant, especially for patients with controlled disease post-induction.

6. Lack of post-progression standard
Despite early closure, most patients did not receive standard second-line chemo-IO. This questions OS benefit attribution solely to cape-ram.”

Title: Maintenance Capecitabine Plus Ramucirumab After First-Line Chemotherapy in Patients With Advanced Esophagogastric Adenocarcinoma: Results From the Randomized PLATFORM Study

Journal: JCO Oncology Advances

Authors: Anderley Gordon, David Cunningham, Zayn Rajan, Caroline Fong, Clare Peckitt, Laura Satchwell, Susan Cromarty, Ian Chau

Read full article.

Sergio Cifuentes

More posts featuring Sergio Cifuentes on OncoDaily.

Sergio Cifuentes highlights key limitations of the PLATFORM study on esophagogastric adenocarcinoma

“Critiques on the PLATFORM study design
(Cape-Ram maintenance after 1L chemo in advanced esophagogastric adenocarcinoma)

1. Phase II, low power
Only 47 patients randomized. Limited statistical power undermines OS analysis and toxicity data robustness. Exploratory, not practice-changing.

2. Early arm closure
Sponsor withdrawal led to premature termination of the cape-ram arm, introducing potential selection bias and affecting study validity.

3. Suboptimal control: surveillance
Control arm was observation, not active treatment. This may inflate cape-ram efficacy vs. an inactive comparator. Not reflective of clinical practice.

4. Obsolete vs. current standard
By design time, CM649 had already shown benefit of chemo+IO followed by IO maintenance. PLATFORM excluded IO entirely—limits its relevance today.

5. Notable toxicity
Grade ≥3 AEs occurred in 57% of cape-ram vs. 32% surveillance. The toxicity burden is significant, especially for patients with controlled disease post-induction.

6. Lack of post-progression standard
Despite early closure, most patients did not receive standard second-line chemo-IO. This questions OS benefit attribution solely to cape-ram.”

Sergio Cifuentes highlights key limitations of the PLATFORM study on esophagogastric adenocarcinoma

“Critiques on the PLATFORM study design (Cape-Ram maintenance after 1L chemo in advanced esophagogastric adenocarcinoma)

1. Phase II, low power Only 47 patients randomized. Limited statistical power undermines OS analysis and toxicity data robustness. Exploratory, not practice-changing.

2. Early arm closure Sponsor withdrawal led to premature termination of the cape-ram arm, introducing potential selection bias and affecting study validity.

3. Suboptimal control: surveillance Control arm was observation, not active treatment. This may inflate cape-ram efficacy vs. an inactive comparator. Not reflective of clinical practice.

4. Obsolete vs. current standard By design time, CM649 had already shown benefit of chemo+IO followed by IO maintenance. PLATFORM excluded IO entirely—limits its relevance today.

5. Notable toxicity Grade ≥3 AEs occurred in 57% of cape-ram vs. 32% surveillance. The toxicity burden is significant, especially for patients with controlled disease post-induction.

6. Lack of post-progression standard Despite early closure, most patients did not receive standard second-line chemo-IO. This questions OS benefit attribution solely to cape-ram.”