From Drug Iteration to a Shift in Philosophy: Prof. Shen Yijun on the Breaking and Building of Bladder Preservation in the ADC 2.0 Era

At the 2026 Pujiang Urologic Oncology Conference in Shanghai

On August 21 and 22, 2026, the Pujiang Urologic Oncology Academic Conference was held in Shanghai. Under the theme of precision integration and innovation for the future, the meeting brought together specialists from across China's urologic oncology field for in-depth exchange on precision diagnosis and treatment, multidisciplinary integration, the translation of innovation into practice, and new models of urologic cancer care.

In an interview recorded at the conference, Prof. Shen Yijun — Chief Physician in the Department of Urology at Fudan University Shanghai Cancer Center, and an invited expert at China Pharmaceutical University's Shanghai GOBROAD Cancer Hospital — systematically set out the dual upgrade now under way in bladder preservation in the ADC 2.0 era: the iteration of the drugs themselves, and a shift in the philosophy and models of bladder-preserving treatment.

Drawing on clinical practice in muscle-invasive bladder cancer (MIBC), he shared his views on risk stratification strategy, the repositioning of the surgeon's role, and the future direction of a selective approach to bladder preservation.

1. In the ADC 2.0 Era, Bladder Preservation Undergoes a Dual Upgrade

Prof. Shen pointed out that bladder preservation in the ADC 2.0 era carries at least two layers of meaning: first, the progress of the drugs themselves; second, the upgrading of the philosophy and models of bladder-preserving treatment.

On the drug side, the concept of the antibody-drug conjugate (ADC) was proposed long ago. After years of development, payloads, conjugation technology, and target selection have been continuously optimized, and both efficacy and adverse-reaction profiles have improved markedly compared with earlier products. First-generation ADCs such as T-DM1 mostly used non-directed, random conjugation, with relatively prominent drug metabolism and off-target effects in the body and more pronounced adverse reactions. Entering the 2.0 era, agents such as enfortumab vedotin and disitamab vedotin, together with new ADCs targeting EGFR, HER3, and TROP2, have appeared one after another, improving on the first generation in payload, conjugation technology, off-target control, efficacy, and safety alike. This progress in the drugs themselves has already given a significant push to bladder preservation in advanced urothelial carcinoma and MIBC.

On the clinical-practice side, bladder-preserving treatment has also gradually entered the 2.0 era, judged both by recent practice and by the real benefit patients have gained. Compared with conventional chemotherapy plus immunotherapy, ADC-based regimens can improve pathological complete response (pCR) and objective response rate (ORR) by roughly 30% to 40%. After conventional neoadjuvant chemotherapy the pCR rate is about 30%, meaning that around 70% of patients still have residual tumor after surgery, and radical cystectomy remains very much necessary. Against a background of ADC combined with immunotherapy, however, the latest data change that picture. These include the EV-303 and EV-304 studies; the SHR-A2102-303 study of SHR-A2102 combined with adebrelimab in the perioperative treatment of MIBC, reported by the urology team of Fudan University Shanghai Cancer Center at the 2026 ASCO Annual Meeting; and the RC48-C017 study of disitamab vedotin. Together they show that pCR rates can rise by about 20% to 30% over conventional chemotherapy, which means that in close to half of patients, no tumor cells can be found after cystectomy.

For patients who reach pCR, long-term outcomes are often good. But performing cystectomy in every case may amount to overtreatment: losing the organ may buy long-term survival while still compromising long-term quality of life. Against a background of rapidly advancing drug therapy, Prof. Shen argued, we need to re-examine the previous one-size-fits-all strategy. Is it still necessary to apply conventional concurrent chemoradiotherapy to every patient without any selection? The bladder-preserving regimen recommended by guidelines — trimodality therapy (TMT), including concurrent chemoradiotherapy — carries a high level of evidence, but much of that evidence base was formed twenty or thirty years ago or even earlier, when the available drugs were limited, mainly chemotherapy agents such as platinum, mitomycin, and gemcitabine. In the ADC era, a more reasonable direction is to perform selective bladder preservation after systemic neoadjuvant therapy in appropriate patients, especially those who have achieved a clinical complete response (cCR). That is more in keeping with the principles of precision and individualization. It is for this reason that the concepts of bladder preservation 2.0 and the ADC treatment 2.0 era were raised at this conference, and that they have real practical necessity.

2. From a Single Imaging Study to Multiple Biomarkers, Risk Stratification Moves Toward Precision Redefinition

Prof. Shen's team previously conducted the Rebirth study in the setting of chemotherapy combined with immunotherapy: patients with MIBC received four cycles of neoadjuvant chemo-immunotherapy, after which risk stratification determined the subsequent path. The core of that risk stratification is whether the patient achieves a cCR. Whether cCR is achieved reflects how sensitive the tumor is to drug treatment. In theory, for those who do not respond to systemic therapy, subsequent benefit from either ADC or immunotherapy may be limited. For this reason, cCR was already used as the screening criterion in the chemo-immunotherapy era, and internationally it is likewise the main basis for deciding subsequent bladder-preserving approaches, including active surveillance, immunotherapy maintenance, or radiotherapy.

In the 2.0 era of ADC combined with immunotherapy, clinical complete response rates have risen further, but cCR remains the key node for selecting candidates for bladder preservation. A number of studies in China and internationally also use cCR as an important evaluation endpoint when judging whether a patient is suitable for subsequent bladder preservation. At the same time, beyond imaging and cystoscopy assessment, biomarkers such as ctDNA and utDNA, and immunohistochemical markers including HER2, should be introduced in the future to further enrich the dimensions of evaluation. It can be expected that in the 2.0 era, the assessment system for risk stratification will become more comprehensive and more precise.

3. From Remover to Gatekeeper, Surgery Finds New Coordinates in the Precision Era

Better efficacy from new drugs does present a challenge to conventional surgical decision-making. For MIBC today, radical cystectomy combined with preoperative neoadjuvant therapy remains the standard pathway, and for the population as a whole it still cannot be said that drug therapy can fully replace local treatment, especially radical cystectomy. Practice in conventional TMT bladder preservation confirms this from another angle: even with that strategy, the proportion of patients who go on to salvage radical surgery because of local tumor recurrence is not low, at roughly 20% to 30%. In addition, adverse reactions related to chemoradiotherapy, and radiotherapy in particular — such as radiation cystitis, repeated bleeding, and reduced bladder capacity and compliance with significantly impaired function — may also force some patients to undergo salvage cystectomy in the end, even when the tumor is already under control.

While systemic treatment advances, surgical technique is advancing too: from open surgery to laparoscopy, to robotics, and on to remote and intelligent surgery. The surgeon's role has not been diminished. In China, most patients with bladder tumors still make their first visit in a surgical department. In the past, MIBC often faced a straightforward decision to remove the bladder; today, more and more patients actively ask whether the bladder can be preserved. This extends the surgeon's role from that of a single operator toward that of a comprehensive assessor. Work such as cystoscopy and transurethral resection (TUR) to assess residual tumor and the degree of response will not be weakened; it needs to be strengthened further. As systemic therapy develops, then, surgical treatment is re-anchoring its own value within the coordinates of the precision-treatment era.

Content source: China Medical Tribune — Oncology Today. Originally published by Shanghai GOBROAD Cancer Hospital on September 4, 2026.

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