Purpose
Pneumococcal vaccination (13-valent pneumococcal conjugate vaccine [PCV13]) is recommended to cancer patients undergoing systemic chemotherapy. However, the optimal time interval between vaccine administration and initiation of chemotherapy has been little studied in adult patients with solid malignancies.
Materials and Methods
We conducted a prospective randomized controlled trial to evaluate whether administering PCV13 on the first day of chemotherapy is non-inferior to vaccinating 2 weeks prior to chemotherapy initiation. Patients were randomly assigned to two study arms, and serum samples were collected at baseline and 4 weeks after vaccination to analyze the serologic response against Streptococcus pneumoniae using a multiplexed opsonophagocytic killing
assay.
Results
Of the 92 patients who underwent randomization, 43 patients in arm A (vaccination 2 weeks before chemotherapy) and 44 patients in arm B (vaccination on the first day of chemotherapy) were analyzed. Immunogenicity was assessed by geometric mean and fold-increase of post-vaccination titers, seroprotection rates (percentage of patients with post-vaccination titers > 1:64), and seroconversion rates (percentage of patients with > 4-fold increase in post-vaccination titers). Serologic responses to PCV13 did not differ significantly between the two study arms according to all three types of assessments.
Conclusion
The overall antibody response to PCV13 is adequate in patients with gastric and colorectal cancer during adjuvant chemotherapy, and no significant difference was found when patients were vaccinated two weeks before or on the day of chemotherapy initiation.
Citations
Citations to this article as recorded by
Vaccination of people with solid tumors and diabetes: existing evidence and recommendations. A position statement from a multidisciplinary panel of scientific societies Marco Gallo, Angioletta Lasagna, Valerio Renzelli, Lelio Morviducci, Alessio Cortellini, Matteo Monami, Giampiero Marino, Stefania Gori, Matteo Verzé, Alberto Ragni, Enzo Tuveri, Laura Sciacca, Stella D’Oronzo, Dario Giuffrida, Annalisa Natalicchio, Franc Journal of Endocrinological Investigation.2025;[Epub] CrossRef
Italian oncologists and vaccinations against infectious diseases: Results of a survey of the Italian Association of Medical Oncology Angioletta Lasagna, Antonella Brunello, Nicola Silvestris, Paolo Pedrazzoli, Massimo Di Maio, Saverio Cinieri Tumori Journal.2024; 110(1): 60. CrossRef
Vaccination of Adults With Cancer: ASCO Guideline Mini Kamboj, Kari Bohlke, Deana M. Baptiste, Kieron Dunleavy, Abbey Fueger, Lee Jones, Amar H. Kelkar, Lisa Y. Law, Kristine B. LeFebvre, Per Ljungman, Eric D. Miller, Larissa A. Meyer, Heather N. Moore, Heloisa P. Soares, Randy A. Taplitz, Edom S. Woldet Journal of Clinical Oncology.2024; 42(14): 1699. CrossRef
Cancer bronchopulmonaire M. Lachâtre, A. Lemaitre, C. Charlier, J. Mazières Revue des Maladies Respiratoires Actualités.2024; 16: e39. CrossRef
Vaccination for seasonal influenza, pneumococcal infection and SARS-CoV-2 in patients with solid tumors: recommendations of the Associazione Italiana di Oncologia Medica (AIOM) P. Pedrazzoli, A. Lasagna, I. Cassaniti, A. Piralla, A. Squeri, R. Bruno, P. Sacchi, F. Baldanti, M. Di Maio, G.D. Beretta, S. Cinieri, N. Silvestris ESMO Open.2023; 8(3): 101215. CrossRef
Pneumococcal Vaccination in Adults: A Narrative Review of Considerations for Individualized Decision-Making Kay Choong See Vaccines.2023; 11(5): 908. CrossRef
Uptake of vaccination in older Indian patients with cancer: A cross-sectional observational study Tabitha M. Sabu, Vanita Noronha, Abhijith R. Rao, Anita Kumar, Shreya Gattani, Anant Ramaswamy, Anupa Pillai, Ratan Dhekale, Renita Castelino, Sharath Kumar, Arshiya Sehgal, Pallavi Rana, Vikram Gota, Rajendra Badwe, Kumar Prabhash Cancer Research, Statistics, and Treatment.2023; 6(1): 52. CrossRef
Review of Vaccination Recommendations in Guidelines for Non-Communicable Diseases with Highest Global Disease Burden among Adults 75 Years Old and Above Abdul Rahman Ishak, Yu Chun Hsieh, Harshitha Srinivasan, Kay Choong See Vaccines.2023; 11(6): 1076. CrossRef
Impact of influenza vaccination on survival of patients with advanced cancer receiving immune checkpoint inhibitors (INVIDIa-2): final results of the multicentre, prospective, observational study Melissa Bersanelli, Elena Verzoni, Alessio Cortellini, Raffaele Giusti, Lorenzo Calvetti, Paola Ermacora, Marilena Di Napoli, Annamaria Catino, Valentina Guadalupi, Giorgia Guaitoli, Vieri Scotti, Francesca Mazzoni, Antonello Veccia, Pamela Francesca Gugl eClinicalMedicine.2023; 61: 102044. CrossRef
Immunological Assessment of Recent Immunotherapy for Colorectal Cancer Subhadeep Das, Diptikanta Acharya Immunological Investigations.2023; 52(8): 1065. CrossRef
Vaccination anti-infectieuse : pour qui ? Quand ? Comment ? M. Lachâtre, M. Murris-Espin, J. Mazières Revue des Maladies Respiratoires Actualités.2023; 15(2): 2S209. CrossRef
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COVID-19 vaccination in cancer patients: a narrative review Suranjith L Seneviratne, Pamodh Yasawardene, Widuranga Wijerathne, Buddhika Somawardana Journal of International Medical Research.2022;[Epub] CrossRef
Invasive pneumococcal disease among adults with hematological and solid organ malignancies: A population-based cohort study Hannah M. Garcia Garrido, Mirjam J. Knol, Jarom Heijmans, Nina M. van Sorge, Elisabeth A.M. Sanders, Heinz-Josef Klümpen, Martin P. Grobusch, Abraham Goorhuis International Journal of Infectious Diseases.2021; 106: 237. CrossRef
Can Cancer Survivors Donate Convalescent Plasma for the Treatment of COVID-19? Ajit Venniyoor Indian Journal of Medical and Paediatric Oncology.2021; 42(01): 021. CrossRef
Reduced humoral immune response after BNT162b2 coronavirus disease 2019 messenger RNA vaccination in cancer patients under antineoplastic treatment M. Peeters, L. Verbruggen, L. Teuwen, G. Vanhoutte, S. Vande Kerckhove, B. Peeters, S. Raats, I. Van der Massen, S. De Keersmaecker, Y. Debie, M. Huizing, P. Pannus, K. Neven, K.K. Ariën, G.A. Martens, M. Van Den Bulcke, E. Roelant, I. Desombere, S. Angui ESMO Open.2021; 6(5): 100274. CrossRef
Recent Topics of Pneumococcal Vaccination: Indication of Pneumococcal Vaccine for Individuals at a Risk of Pneumococcal Disease in Adults Nobuhiro Asai, Hiroshige Mikamo Microorganisms.2021; 9(11): 2342. CrossRef
Vaccination practices, efficacy, and safety in adults with cancer Laboni Sarkar, Vasu Babu Goli, Nandini Menon, Vijay Maruti Patil, Vanita Noronha, Kumar Prabhash Cancer Research, Statistics, and Treatment.2021; 4(3): 505. CrossRef
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Cancer Res Treat. 2019;51(2):718-726. Published online September 3, 2018
Purpose
The optimal cytotoxic regimens have not been established for patients with non-small cell lung cancer (NSCLC) who develop disease progression on first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).
Materials and Methods
We conducted a multi-center randomized phase II trial to compare the clinical outcomes between pemetrexed plus cisplatin combination therapy followed by maintenance pemetrexed (PC) and pemetrexed monotherapy (P) after failure of first-line EGFR-TKI. The primary objective was progression-free survival (PFS), and secondary objectives included overall response rate (ORR), overall survival (OS), health-related quality of life (HRQOL), and safety and toxicity profiles.
Results
A total of 96 patientswere randomized, and 91 patientswere treated at 14 centers in Korea. The ORR was 34.8% (16/46) for the PC arm and 17.8% (8/45) for the P arm (p=0.066). With 23.4 months of follow-up, the median PFS was 5.4 months in the PC arm and 6.4 months in the P arm (p=0.114). The median OS was 17.9 months and 15.7 months in PC and P arms, respectively (p=0.787). Adverse events ≥ grade 3 were reported in 12 patients (26.1%) in the PC arm and nine patients (20.0%) in the P arm (p=0.491). The overall time trends of HRQOL were not significantly different between the two arms.
Conclusion
The outcomes of pemetrexed therapy in NSCLC patients with disease progression after firstline EGFR-TKI might not be improved by adding cisplatin.
Citations
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The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yu Cancer Research and Treatment.2025; 57(1): 39. CrossRef
A randomised non-comparative phase II study of atezolizumab, bevacizumab and chemotherapy in EGFR-mutant NSCLC with acquired resistance – The ETOP 15-19 ABC-lung trial R.A. Soo, K. Vervita, M. Früh, B.C. Cho, M. Majem, D. Rodriguez Abreu, K. Ribi, A. Callejo, T. Moran, M. Domine Gomez, M. Provencio, A. Addeo, J.Y. Han, A.L. Ortega Granados, M. Reck, A. Blasco, R. Garcia Campelo, M.A. Sala González, C. Britschgi, H. Rosc Lung Cancer.2025; 202: 108454. CrossRef
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