Tumour Burden Reporting in Phase III Clinical Trials of Metastatic Lung, Breast, and Colorectal Cancers: A Systematic Review
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Search Strategy and Selection Criteria
2.2. Study Check and Quality Rating
2.3. Variables
2.4. Data Reporting and Analysis
3. Results
3.1. Study Selection
3.2. Study Characteristics
3.3. Reporting of Disease Extent in the Selected Trials
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Booth, C.M.; Cescon, D.W.; Wang, L.; Tannock, I.F.; Krzyzanowska, M.K. Evolution of the randomized controlled trial in oncology over three decades. J. Clin. Oncol. 2008, 26, 5458–5464. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Tannock, I.F.; Amir, E.; Booth, C.M.; Niraula, S.; Ocana, A.; Seruga, B.; Templeton, A.J.; Vera-Badillo, F. Relevance of randomised controlled trials in oncology. Lancet Oncol. 2016, 17, e560–e567. [Google Scholar] [CrossRef]
- Hellman, S.; Weichselbaum, R.R. Oligometastases. J. Clin. Oncol. 1995, 13, 8–10. [Google Scholar] [CrossRef] [PubMed]
- Niibe, Y.; Chang, J.Y.; Onishi, H.; Salama, J.; Hiraki, T.; Yamashita, H. Oligometastases/Oligo-recurrence of lung cancer. Pulm. Med. 2013, 2013, 438236. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Huang, F.; Wu, G.; Yang, K. Oligometastasis and oligo-recurrence: More than a mirage. Radiat. Oncol. 2014, 9, 230. [Google Scholar] [CrossRef] [PubMed]
- Withers, H.R.; Lee, S.P. Modeling growth kinetics and statistical distribution of oligometastases. Semin. Radiat. Oncol. 2016, 16, 111–119. [Google Scholar] [CrossRef] [PubMed]
- Lievens, Y.; Guckenberger, M.; Gomez, D.; Hoyer, M.; Iyengar, P.; Kindts, I.; Romero, A.M.; Nevens, D.; Palma, D.; Park, C.; et al. Defining oligometastatic disease from a radiation oncology perspective: An ESTRO-ASTRO consensus document. Radiother. Oncol. 2020, 148, 157–166. [Google Scholar] [CrossRef] [PubMed]
- Guckenberger, M.; Lievens, Y.; Bouma, A.B.; Collette, L.; Dekker, A.; Nandita, M.D.; Dingemans, A.M.; Fournier, B.; Hurkmans, C.; Lecouvet, F.E.; et al. Characterisation and classification of oligometastatic disease: A European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020, 21, e18–e28. [Google Scholar] [CrossRef] [Green Version]
- Rusthoven, K.E.; Kavanagh, B.D.; Burri, S.H. Multi-Institutional Phase I/II Trial of Stereotactic Body Radiation Therapy for Lung Metastases. J. Clin. Oncol. 2009, 27, 1579–1584. [Google Scholar] [CrossRef] [PubMed]
- Ottaiano, A.; Scotti, V.; De Divitiis, C.; Capozzi, M.; Romano, C.; Cassata, A.; Casaretti, R.; Silvestro, L.; Nappi, A.; Vicario, V.; et al. Integration of stereotactic radiotherapy in the treatment of metastatic colorectal cancer patients: A real practice study with long-term outcome and prognostic factors. Oncotarget 2018, 9, 35251–35265. [Google Scholar] [CrossRef] [PubMed]
- Ottaiano, A.; Santorsola, M.; Caraglia, M.; Circelli, L.; Gigantino, V.; Botti, G.; Nasti, G. Genetic regressive trajectories in colorectal cancer: A new hallmark of oligo-metastatic disease? Transl. Oncol. 2021, 14, 101131. [Google Scholar] [CrossRef] [PubMed]
- Ottaiano, A.; Santorsola, M.; Caracò, F.; Caraglia, M.; Nasti, G. Initial tumour burden and hidden oligometastatic disease in phase 3 clinical trials. Lancet Oncol. 2022, 23, 452–454. [Google Scholar] [CrossRef]
- Shamseer, L.; Moher, D.; Clarke, M.; Ghersi, D.; Liberati, A.; Petticrew, M.; Shekelle, P.; Stewart, L.A.; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015, Elaboration and explanation. BMJ 2015, 350, g7647. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Sung, H.; Ferlay, J.; Siegel, R.L.; Laversanne, M.; Soerjomataram, I.; Jemal, A.; Bray, F. Global Cancer Statistics 2020, GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J. Clin. 2021, 71, 209–249. [Google Scholar] [CrossRef] [PubMed]
- Péron, J.; Pond, G.R.; Gan, H.K.; Chen, E.X.; Almufti, R.; Maillet, D.; You, B. Quality of Reporting of Modern Randomized Controlled Trials in Medical Oncology: A Systematic Review. JNCI J. Natl. Cancer Inst. 2012, 104, 982–989. [Google Scholar] [CrossRef] [PubMed]
- Gan, H.K.; You, B.; Pond, G.R.; Chen, E.X. Assumptions of Expected Benefits in Randomized Phase III Trials Evaluating Systemic Treatments for Cancer. JNCI J. Natl. Cancer Inst. 2012, 104, 590–598. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Kim, S.I.; Cassella, C.R.; Byrne, K.T. Tumor Burden and Immunotherapy: Impact on Immune Infiltration and Therapeutic Outcomes. Front. Immunol. 2021, 11, 629722. [Google Scholar] [CrossRef] [PubMed]
Characteristic | No. | % |
---|---|---|
Type of cancer | ||
Non-small-cell lung cancer | 43 | 61.4 |
Breast | 17 | 24.3 |
Colorectal | 10 | 14.3 |
Sample size | ||
Median | 442 | |
Range | 32–1486 | |
Type of therapy | ||
Signal inhibitors (including antibodies and small molecules) | 17 | 24.3 |
Immuno-therapy | 12 | 17.1 |
Chemotherapy | 10 | 14.3 |
Associations | 31 | 44.3 |
Chemotherapy + signal inhibitors | 16 | |
Chemotherapy + immuno-therapy | 8 | |
Signal inhibitors + hormone-therapy | 4 | |
Chemotherapy + signal inhibitors + immuno-therapy | 3 | |
Primary end-points | ||
PFS | 44 | 62.8 |
OS | 13 | 18.6 |
PFS and OS | 13 | 18.6 |
Study conclusions | ||
Positive | 45 | 64.3 |
Negative | 17 | 24.3 |
Non-inferior | 7 | 10.0 |
Equivalent | 1 | 1.4 |
Inclusion of placebo in the control arm | ||
Yes | 22 | 31.4 |
No | 48 | 68.6 |
Characteristics | No. | % |
---|---|---|
Reporting of low-burden disease | ||
Yes | 20 | 28.6 |
No | 50 | 71.4 |
Identification modality | ||
No. of metastatic sites | 19 | 27.1 |
Tumour diameter | 1 | 1.4 |
Not reported | 50 | 71.4 |
Disease extent as a stratification factor | ||
Yes | 18 | 25.7 |
No | 52 | 74.3 |
Low-burden disease per treatment arm | ||
Yes | 19 | 27.1 |
No | 51 | 72.9 |
Reporting of oligo-metastatic disease | ||
Yes | 0 | 0 |
No | 70 | 100 |
Subgroup analysis according to disease extent | ||
Yes | 13 | 18.6 |
No | 57 | 81.3 |
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Santorsola, M.; Di Lauro, V.; Nasti, G.; Caraglia, M.; Capuozzo, M.; Perri, F.; Cascella, M.; Misso, G.; Ottaiano, A. Tumour Burden Reporting in Phase III Clinical Trials of Metastatic Lung, Breast, and Colorectal Cancers: A Systematic Review. Cancers 2022, 14, 3262. https://doi.org/10.3390/cancers14133262
Santorsola M, Di Lauro V, Nasti G, Caraglia M, Capuozzo M, Perri F, Cascella M, Misso G, Ottaiano A. Tumour Burden Reporting in Phase III Clinical Trials of Metastatic Lung, Breast, and Colorectal Cancers: A Systematic Review. Cancers. 2022; 14(13):3262. https://doi.org/10.3390/cancers14133262
Chicago/Turabian StyleSantorsola, Mariachiara, Vincenzo Di Lauro, Guglielmo Nasti, Michele Caraglia, Maurizio Capuozzo, Francesco Perri, Marco Cascella, Gabriella Misso, and Alessandro Ottaiano. 2022. "Tumour Burden Reporting in Phase III Clinical Trials of Metastatic Lung, Breast, and Colorectal Cancers: A Systematic Review" Cancers 14, no. 13: 3262. https://doi.org/10.3390/cancers14133262