Power of Data Sharing

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Patty Spears

One of the most valuable contributions a patient can make to science is to donate tumor tissue for research. It is important to use the tissue in research in a way that respects the intentions of the patient who donated it.  Tumor tissue can continue to add value to research, beyond the original study.  One way to add value is to share data with other researchers to combine it with data from similar studies.

A recent publication illustrates the power of data sharing from tissue and data collected in three clinical trials.¹  The trials were conducted between 2007 and 2014.  The data from these trials continues to contribute to discoveries long after the original trials have ended.  This is because of data sharing. By sharing tissue and data, more discoveries can be made that add value to patient care.

These three trials tested HER2-targeted treatments in early-stage breast cancer given before surgery.^2,3,4  They compared using a single HER2 targeted drug alone (H, trastuzumab or L, lapatinib) to using both HER2 targeted drugs together (H and L).

In each trial there were enough patients to look at the primary endpoint of pathologic complete response (pCR) at surgery.  However, there were not enough patients to look at more clinically relevant endpoints like event-free survival (EFS).  They also wanted to look at molecular markers relating to clinical outcomes.

To do this, they combined information from patients in all three trials.  They combined tumor gene expression data in a pooled analysis to look at single HER2 blockade versus dual HER2 blockade in more patients.  Then they added patient clinical information and looked at many more characteristics of these patients. 

By combining the information from three trials, they could look at clinical outcomes in several different ways:

• Patient characteristics
• Clinical subtype
• Molecular subtype
• pCR status
• Tumor-related gene signatures
• Immune-related gene signatures

Listed below is what they found by combining data from the three trials.  This is information they could not determine in each individual trial.

• The association between pCR and EFS differed by molecular subtype.  
• Patients with tumors of a specific tumor molecular subtype benefited from dual HER2 targeting.
• A specific immune-activated molecular signature was associated with higher pCR and better EFS.

Conclusion

This information will help patients choose the best treatment option for them.  Patients are challenged to make choices about different treatment options.  Shedding light on which treatment may work best on their tumor would be a huge step forward for patients.  This means patients have an opportunity to receive the best treatments for their cancer.

Thank you to all the patients who took part in the three clinical trials and donated their tumor tissue and information for research. (NeoALTTO – NCT00553358, CALGB 40601 – NCT00770809, NSABP B-41 – NCT00486668)

All Image Sources: Created by Author with Microsoft PowerPoint

Edited by Dr Alina Panjwani

References

1. Fernandez-Martinez A, et al. Tumor Intrinsic Subtypes and Gene Expression Signatures in Early-Stage ERBB2/HER2-Positive Breast Cancer: A Pooled Analysis of CALGB 40601, NeoALTTO, and NSABP B-41 Trials. JAMA Oncol. 2024 May 1;10(5):603-611. PMID: 38546612; PMCID: PMC10979363.
2. Baselga J, er al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. Erratum in: Lancet. 2012 Feb 18;379(9816):616. PMID: 22257673; PMCID: PMC5705192.
3. Carey LA, et al. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. J Clin Oncol. 2016 Feb 20;34(6):542-9. PMID: 26527775; PMCID: PMC4980567.
4. Robidoux A, et al. Lapatinib as a component of neoadjuvant therapy for HER2-positive operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1183-92. PMID: 24095300.