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Abstract
Objectives
Although neoadjuvant chemotherapy (NAC) has been demonstrated to have significant
benefits to survival in patients with muscle-invasive bladder cancer (MIBC), the current
utilization of NAC in Australia is unknown. The aim of this study was to evaluate
the patterns of neoadjuvant and adjuvant chemotherapy (AC) use in patients undergoing
cystectomy for MIBC at a large tertiary institution in Australia.
Methods
A retrospective study was conducted using data of patients who underwent a radical
cystectomy (RC) at a high-volume centre for MIBC between 2011 and 2021.
Results
Of 69 patients who had a cystectomy for ≥ pT2 bladder cancer, 73.9% were eligible
for NAC. However, of those eligible, only five patients received NAC (9.8%). Of the
total patients who were eligible for AC, only 44.4% received postoperative chemotherapy.
Common reasons for the lack of uptake were due to patients being unfit or declining
treatment. There was no difference in progression-free survival or overall survival
in those who received NAC and AC.
Conclusions
The majority of patients undergoing RC for MIBC received AC compared to NAC, reflecting
the real-world challenge of NAC uptake. This highlights the need for ongoing improvements
in selection and usage of NAC and less reliance of AC utilization post RC.
Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.
[1
]Department of Urology, Monash Health , Casey, VIC, Australia
[2
]School of Clinical Sciences, Monash University , Clayton, VIC, Australia
[3
]Department of Oncology, Monash Health , Clayton, VIC, Australia
[4
]Department of Anatomy and Developmental Biology, Monash University , Clayton, VIC, Australia
Author notes
*
Corresponding author: Dr Kylie Yen-Yi Lim, Department of Urology, Monash Health – Casey Hospital, 62-70
Kangan Dr, Berwick, Victoria 3806; Phone +61 9594 6666; Email:
kylielim7@
123456gmail.com
Declaration of interests: There is no conflict of interest associated with this publication and no financial
support was required at time of submission.
Abbreviation used: AC, adjuvant chemotherapy; CTCAE, common terminology criteria for adverse events;
CTCAP, computerised tomography chest, abdominal and pelvic; ddMVAC, dose dense methotrexate
vinblastine doxorubicin cisplatin; IQR, interquartile range; MIBC, muscle invasive
bladder cancer; NAC, neoadjuvant chemotherapy; NCDB, National Cancer Database; NYHA,
New York Heart Association; RECIST, response evaluation criteria in solid tumours;
RC, radical cystectomy; SEER, Surveillance, Epidemiology and End Results; TURBT, transurethral
resection of bladder tumour
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