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We report a diffuse hypermetabolic micronodular lung disease (miliary pattern) in a 61-year-old man who underwent a PET/CT-scan for unexplain asthenia associated with fever symptoms. The patient had a history of urothelial bladder carcinoma treated with transurethral resection and immunotherapy with BCG (Bacille Calmette–Guerin) one year ago. After two month of specific BCG-infection treatment, the post-therapeutic evaluation by 18F-FDG PET/CT show an excellent response of the hypermetabolic pulmonary milary and confirm the diagnosis of BCGitis. This rare case of “BCGitis” after BCG-therapy for an urothelial bladder carcinoma highlights the importance to sensitize nuclear physicians on the etiologies of miliary (BCGite vs. metastases), and on the importance of taking into account the history of the patients thanks to the interrogation.

To evaluate the efficacy and safety of a tailored endovesical immunotherapy protocol with biweekly BCG for elderly Patients with high risk non muscle invasive bladder cancer (HG-NMIBC).We retrospectively evaluated data from 200 patients older than 80 years newly diagnosed with HG-NMIBC: 100 (group 1) with multiple comorbidities (WHO PS 2-3, ASA score ≥3, Charlson Comorbidity index ≥3, GFR60 mL/min) were treated with BCG induction course administered biweekly; 100 (group 2) with statistically significant better conditions were treated with standard weekly BCG therapy. After the induction treatment disease-free patients underwent to at least one year of BCG maintenance therapy. Endpoints were: initial response to BCG, cancer-free survival and rate of progression at 2 years, rate of complications.No statistically significant differences were found in terms of initial response to BCG (69% in Group 1 vs 71% in Group 2, P = 0.75), cancer free survival (57% vs 55% respectively, P = 0.77) and rate of progression (20% vs 14% respectively, P = 0.26) at 2 years. The difference in the rate of overall complications was statistically significant (15% in Group 1 vs 27% in Group 2, P = 0.03), in the rate of severe complications was not statistically significant (5% in Group 1 vs 7% in Group 2, P = 0.61).A tailored regimen of BCG administration is possible and safe in frail elderly patients, limiting side effects and risk of undertreatment but maintaining oncological outcomes. Preliminary results in a small patients group are promising but larger randomized studies are needed to confirm our data.

Penile granulomas has been rarely reported in the setting of BCG instillations. We present a 70 year-old male with multiple penile granulomas during BCG instillations due a high-grade urothelial bladder cancer. Histopathological study revealed granulomatous structures with central necrosis as seen after BCG therapy. Local treatment with cryotherapy has been shown to be effective. This case emphasizes the importance to suspect this adverse effect in patients under BCG treatment.

The overall efficacy of BCG therapy is remarkably high but the mechanism of its action is still elusive. The success of BCG therapy depends on several factors that may give clues to its effector mechanism: a competent immune system, a sufficient number of live BCG, a development of fever and the death of cancer cells. Here we propose a theory for the action mechanism of the BCG therapy for the bladder cancer treatment by establishing the logical connection of these required elements. The center concept of the BCG therapy mechanism is to activate granulocytes that in turn kill bladder cancer cells directly by its major effector mechanism: degranulation.

Therapie - In Press.Proof corrected by the author Available online since dimanche 19 mars 2017

Background Efficacy and safety of pembro in pts with HR BCG-unresponsive NMIBC was evaluated in the single-arm phase 2 KEYNOTE-057 study (NCT02625961); updated follow-up of interim data and exploratory HRQoL analyses are reported. Methods Pts with histologically confirmed HR BCG-unresponsive CIS with or without papillary tumors who received adequate BCG therapy and who were ineligible or refused radical cystectomy (cohort A) were eligible. Pts received pembro 200 mg Q3W for 24 mo or until recurrence, progression, or unacceptable toxicity; those who developed HR NMIBC or progressive disease were required to discontinue. Key end points: complete response rate (CRR), duration of response, and safety. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl) scale. Results 102 pts enrolled in cohort A as of enrollment cutoff. Median (range) duration of follow-up was 21.1 mo (4.6-33.4); CRR was 41.2% (95% CI, 31.5-51.4) by central assessment. Among 42 pts with CR, median CR duration was 13.5 mo (range, 0+ to 26.8+); 57.4% had CR ≥ 12 mo (Kaplan-Meier). 22 pts (52.4%) maintained CR at last follow-up. 20 (47.6%) experienced recurrent NMIBC after CR. At time of analysis, there were no occurrences of progression to muscle-invasive disease (T2) or metastatic bladder cancer. For pts with CR, HRQoL was stable over time. At a prespecified analysis timepoint of week 39, the majority of pts (71.1% for FACT-G total and 77.8% for FACT-G physical well-being score) had improved (≥7 or ≥ 3 point increase, respectively) or stable (change between –7 and +7 or –3 and +3 points, respectively) scores from baseline. Treatment-related adverse events (TRAEs) occurred in 67 (65.7%) pts; most frequent (≥10%) were fatigue (10.8%), pruritus (10.8%), and diarrhea (10.8%). Grade 3/4 TRAEs occurred in 13 (12.7%) pts. Conclusions Pembro continued to show encouraging antitumor activity in pts with HR BCG-unresponsive CIS with or without papillary tumors plus maintenance of HRQoL. The safety profile was consistent with the known profile of pembro. Clinical trial identification NCT02625961; December 9, 2015. Editorial acknowledgement Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA), funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Legal entity responsible for the study Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Disclosure R. de Wit: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Research grant / Funding (institution): Bayer; Honoraria (self): Janssen; Advisory / Consultancy: Clovis. G.S. Kulkarni: Advisory / Consultancy: Ferring; Advisory / Consultancy: Janssen; Advisory / Consultancy: Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Theralase; Research grant / Funding (self): Biosyent; Honoraria (self), Travel / Accommodation / Expenses: AbbVie; Honoraria (self), Travel / Accommodation / Expenses: TerSera; Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy: Amgen. J.L. Boormans: Advisory / Consultancy: BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Janssen; Research grant / Funding (self): GenomeDx Biosciences. L.E.M. Krieger: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas. E.A. Singer: Research grant / Funding (self): Astellas/Medivation. D.F. Bajorin: Advisory / Consultancy, Research grant / Funding (self): Merck; Advisory / Consultancy: Genentech; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Urogen; Advisory / Consultancy, Research grant / Funding (self): Novartis. A.M. Kamat: Research grant / Funding (institution): FKD; Honoraria (self), Research grant / Funding (institution): Merck; Research grant / Funding (institution): Telesta; Research grant / Funding (institution): Adolor; Honoraria (self): TMC Innovation; Honoraria (self): BMS; Honoraria (self): Arquer; Honoraria (self): MDxHealth; Honoraria (self): Photocure; Honoraria (self): Theralase; Honoraria (self): Cepheid; Honoraria (self): Medac; Honoraria (self): Asieris; Honoraria (self): Pfizer; Honoraria (self): AstraZeneca. P. Grivas: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck & Co., Inc.; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Educational unbranded activity: Genentech; Honoraria (self), Advisory / Consultancy: Dendreon; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bayer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Educational unbranded activity: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Exelixis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Biocept; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Clovis Oncology; Honoraria (self), Advisory / Consultancy: EMD Serono; Honoraria (self), Advisory / Consultancy: Seattle Genetics; Honoraria (self), Advisory / Consultancy: Foundation Medicine; Honoraria (self), Advisory / Consultancy: Driver Inc.; Honoraria (self), Advisory / Consultancy: QED Therapeutics; Honoraria (self), Advisory / Consultancy: Heron Therapeutics; Honoraria (self), Advisory / Consultancy: Janssen; Research grant / Funding (institution): Mirati; Research grant / Funding (institution): Oncogenex; Research grant / Funding (institution): Bavarian Nordic, Immunomedics. B.R. Konety: Advisory / Consultancy, Research grant / Funding (institution): Photocure; Advisory / Consultancy: Pacific Edge; Advisory / Consultancy: Taris; Advisory / Consultancy: Boston Scientific; Advisory / Consultancy: NxThera; Research grant / Funding (institution): Genomic Health; Research grant / Funding (institution): Merck; Research grant / Funding (institution): BMS. T. Saretsky: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck and Co., Inc. H. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck. K. Nam: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck. E. Sbar: Leadership role, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: MSD; Shareholder / Stockholder / Stock options: BMS; Shareholder / Stockholder / Stock options: Pfizer. A.V. Balar: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Genentech; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy: Pfizer/EMD Serono. All other authors have declared no conflicts of interest.

Resume Dans le cancer du rein, le PET CaIX se revele etre un potentiel nouvel outil diagnostique et de monitoring. Il n’a pas ete note d’avancee pour les associations de traitements medicaux (le standard restant le traitement sequentiel). Il n’existe pas de critere reconnu pour la selection des bons candidats a l’immunotherapie. En cas de maladie d’emblee metastatique la nephrectomie reste a discuter. L’etude CARMENA permettra de determiner son utilite. Dans le futur, on attend beaucoup l’emergence de la determination du risque de recidive apres nephrectomie au moyen d’etude genomique. Concernant les tumeurs de vessie n’infiltrant pas le muscle, le diagnostic endoscopique semble ameliore par le NBI et l’immunofluorescence. La stadification des tumeurs pT1 pourrait evoluer. Le pronostic pejoratif du Cis a ete souligne. La place de la cystectomie pour les echecs de BCG a ete precisee. Pour les tumeurs de vessie infiltrant le muscle, l’impact pronostic de l’invasion lymphovasculaire a ete rapporte. L’importance d’un curage ganglionnaire etendu a ete demontree. En cas de metastase osseuse symptomatique, l’acide zoledronique a augmente la survie globale. Pour le cancer de la prostate, le denosumab et l’acide zoledronique ont ete compares en prevention primaire de la perte osseuse sous privation androgenique. Les antagonistes de la LH-RH, le cabazitaxel et les immunotherapies pourraient faire partie des alternatives therapeutiques du cancer prostatique avance. Concernant le cancer du penis, la cytoponction couplee a l’echographie et le PET-Scan ont confirme leur interet dans l’evaluation ganglionnaire. Les performances et inconvenients de l’hormono-radiotherapie ont ete analyses. Dans les tumeurs testiculaires, le taux de recidive chez les patients suivis pour un seminome de stade I a ete evalue a 15 %. Le PET-Scan pourrait permettre de mieux selectionner les patients avant chimiotherapie adjuvante et exerese des masses residuelles.

Resume Introduction Si les manifestations locales induites par la Bacillus Calmette Guerin (BCG)-therapie intravesicale sont frequentes, les complications liees a une dissemination hematogene sont plus rares. De meme, le risque de developper des complications osteo-articulaires non infectieuses liees a la BCG-therapie intravesicale est estime entre 0,5 a 1 %. Observations Nous rapportons deux observations de patients suivis pour tumeur superficielle de la vessie ayant developpe une polyarthrite febrile apres une cure de BCG-therapie intravesicale. Le diagnostic retenu dans les deux cas etait celui d’arthrites reactionnelles a la BCG-therapie. Chez ces deux patients, le traitement par anti-inflammatoires non steroidiens etait efficace permettant la regression de l’ensemble de la symptomatologie clinique. Conclusion L’osteoarthrite a Mycobacterium bovis demeure la complication osteo-articulaire la plus redoutee et doit etre eliminee devant toute manifestation articulaire survenant chez les patients traites par BCG-therapie intravesicale. De fait, les analyses microbiologiques du liquide articulaire (examen direct, cultures, PCR) sont indispensables chez ces patients afin de s’affranchir d’une infection secondaire et pour porter le diagnostic d’arthrite reactionnelle a la BCG-therapie.

Bacillus Calmette-Guerin (BCG) is still the most appropriate primary therapy for high-risk patients and appropriate primary or secondary therapy for patients with intermediate-risk disease. The highest disease-free rates will be found in patients who are BCG naïve, have low tumor burden, are stage Ta or CIS, and those relatively younger (80 years). Repeat transurethral resection (TUR) for stage T1 disease, BCG maintenance, and dose/regimen alterations are likely to improve efficacy and/or tolerability. There is potential utility for antifibrinolytic drugs, cytokine supplementation (IL2/IFN), and Cox-2 inhibitors. BCG failures continue to present unique challenges with a relatively narrow window of safety for repeat BCG use. Those who fail BCG repeatedly early are at an especially high risk for progression and should be offered expedient curative cystectomy whenever feasible. While not without risk, certain select patients may still be appropriate for alternative conservative therapy.

Resume Introduction La BCGtherapie est un traitement adjuvant efficace des tumeurs superficielles de vessie. Elle consiste en l’instillation intravesicale de bacilles vivants attenues de Calmette-Guerin. La BCGite du gland est une complication locale rare de ce traitement dont nous rapportons deux cas. Observations Cas 1 : un homme de 77 ans avait une recidive de carcinome urothelial de vessie traitee par resection endoscopique suivie d’une BCGtherapie. Une semaine apres la septieme instillation apparaissait une balanite intense. Trois mois plus tard, l’examen trouvait une vaste ulceration perimeatique douloureuse avec des papules jaunâtres en peripherie. L’examen histologique montrait des granulomes epithelioides et gigantocellulaires. La coloration de Ziehl-Neelsen etait positive. Une bi-antibiotherapie antituberculeuse permettait une lente guerison des lesions en 12 mois. Cas 2 : un homme de 61 ans etait traite par BCGtherapie pour la recidive d’un carcinome vesical in situ. La sixieme instillation etait consideree traumatique, car tres douloureuse. Une semaine plus tard, apparaissaient des papulonodules du gland avec une lesion sclereuse du sillon balanopreputial, une atteinte papuleuse violine perimeatique et une masse sous-muqueuse du gland. Une antibiotherapie par ofloxacine puis par rifampicine pendant deux mois etait inefficace. L’examen histologique trouvait des lesions granulomateuses dermiques avec une necrose eosinophile. Une tri-antibiotherapie antituberculeuse etait entreprise. Discussion Le premier cas de BCGite du gland compliquant une BCGtherapie intravesicale a ete publie en 1992. Depuis, neuf autres cas ont ete rapportes. La presentation clinique n’est pas stereotypee. Il s’agit souvent d’un placard erythemateux infiltre avec parfois des papules jaunâtres associees. Le diagnostic repose sur l’anamnese et l’examen histologique.

Local Bacillus Calmette-Guerin (BCG) immunotherapy is an effective and widely used treatment for superficial bladder carcinoma. Local side effects are frequent, whereas systemic side effects are rare, but more serious. We report four cases of systemic BCG reaction. Although uncommon, this infectious complication of BCG therapy should always be considered in the appropriate clinical setting. The best approach to minimize this complication is a strict compliance with precautions and a close and rigorous surveillance of this drug.

OBJECTIVES To determine the influence of age on the outcomes of high-risk superficial bladder cancer treated with intravesical bacille Calmette-Guerin (BCG) therapy. METHODS A total of 805 patients with multiple or recurrent high-grade Ta, T1, and/or carcinoma in situ bladder cancer received BCG therapy. The endpoints were the initial response to BCG and cancer-free survival correlated with age among patients followed up for a minimum of 2 to 5 years. RESULTS No difference was observed in the first response to BCG or cancer-free survival at 2 years among patients less than 50, 50 to 59, 60 to 69, 70 to 79, or 80 years or older. After 5 years, 27% of patients older than 70 years were cancer free compared with 37% younger than 70 years (P = 0.005). CONCLUSIONS The results of our study have shown that aging has a measurable, but small, impact on the overall outcomes of high-risk superficial bladder cancer.

Objectives This paper describes and discusses the most relevant new findings on bladder cancer (BCa) that were presented at the 2006 annual meetings from the European Association of Urology (EAU), American Urological Association (AUA) and the American Society of Clinical Oncology (ASCO). Methods The most relevant abstracts on BCa were selected by experts in the field of BCa and discussed during a closed meeting. Results The most relevant new data on BCa came from the EAU and AUA meetings. Major topic of the meetings was the development of the EORTC prognostic tables to calculate short- and long-term recurrence and progression rates of patients with superficial BCa. Many (controversial) studies discussed the diagnostic and prognostic potentials of the biomarkers survivin and NMP22. Two studies involved the treatment of patients with refractory superficial BCa. Intravesical therapy with Bacillus Calmette-Guerin+interferon-α was considered a promising therapy for patients who failed BCG therapy. With respect to invasive BCa, there were some controversial reports on the impact of delayed cystectomy or hospital volumes on (cancer-free) survival rates. The bladder cancer index was presented as a promising questionnaire to assess quality of life in patients with localised BCa. Finally, one study showed that extensive tumour necrosis in upper urinary tract tumours is a prognostic factor for poor patient outcome. Conclusions There were many interesting studies about BCa at this year's urologic meetings. Major headline was the introduction of the EORTC prognostic tables, which will probably lead to a major improvement in the evaluation and surveillance of patients with superficial BCa.

The authors report 24 patients presenting a transitional tumor of bladder pT1G3 collected between January 1996 and December 2000. They represent 19% of the superficial tumors of bladder. Two patients had of straightaway a cystectomy after resection for an unverifiable tumor by endoscopy and another after a second resection discovering a real pT2. Only 5 patients received a BCG therapy is 24% of the cases. A recurrence without progression has been noted in 38% of the cases and a progression in 19% of the patients. These last patients had a cystectomy and with a follow-up to 28 months, no recurrence has been noted.

BCG is currently the most active immunotherapy agent for intravesical use and is considered the first-line treatment for patients with aggressive T1 G3 and Tis superficial tumors of the bladder. Its main drawback, toxicity, is being addressed by several prospective studies that try to find the lowest active dose and optimal schedule, as well as by studies investigating the efficacy of antigenic bacterial fractions, devoid of the toxicity of the living bacilli. Efforts to improve the efficacy by combination with chemotherapy and biomodulating natural remedies are also under way. In this review we discuss: (1) the indications, limits and contraindications of BCG; (2) the efficacy; (3) the strains; (4) route of administration; (5) dose; (6) schedule; (7) the problem of toxicity, and (8) how to improve BCG therapy.

The standard of practice set by the SWOG investigation of BCG therapy for superficial bladder cancer has been to evaluate response at 3 months with cystoscopy and bladder biopsy. This study is to determine if all patients require a biopsy post therapy at 3 or 6 months. We reviewed the charts of 43 patients who had received a 6-weekly course of BCG (Connaught strain) for high grade or recurrent Ta, T1, or Tis transitional cell carcinoma of the bladder. The patients with Ta recurrent, T1 or Tis disease received maintenance therapy. All patients were followed through 6 months. At 3 months, 32/43 patients had negative cystoscopies. All 32 patients had corresponding negative biopsies. Eight patients had visible papillary tumors, while three patients had erythematous lesions, which were biopsy negative. At 6 months, eight different patients had visible lesions on cystoscopy that were biopsy proven superficial bladder cancer. The positive predictive value at 3 and 6 months post BCG therapy was 72.6% and 100%, respectively. The false positive rate was 7% at the 3-month checkpoint. Bladder biopsy is not necessary at the 3 or 6 month period following BCG therapy in the face of negative cystoscopic findings.

Shortly after Morales' original report, several phase II trials confirmed the effectiveness of intravesical bacillus Calmette-Guérin (BCG) in superficial bladder cancer therapy. Concerns have been expressed about the toxicity related to this new therapeutic modality. These phase II trial data led European urologists to try to answer some questions related to BCG therapy, such as the optimal schedule and dose, the most effective BCG strain and the value of BCG compared with current chemotherapeutic drugs. To date, phase III trials have shown that BCG is more effective than thiotepa and doxorubicin in reducing tumour recurrences and progression and that BCG seems to be as effective as mitomycin C. Toxicity is significantly higher with BCG compared to chemotherapeutic drugs; no strain of BCG seems to be superior in this respect. Further studies are required to identify the optimal schedule and dose, as well as the best therapeutic efficacy/toxicity ratio.

Bacillus Calmette-Guérin (BCG) immunotherapy represents a valuable treatment in the management of superficial bladder cancer, but the therapy is not without its risks. A total of 220 patients have been included in a review of local and systemic side effects associated with BCG immunotherapy. The majority of side effects are mild and self limiting, but potentially life threatening complications can arise with BCG immunotherapy. These systemic side effects include pneumonitis/hepatitis and systemic BCG infection. Recommendations are given for the use and administration of BCG, and if these rules are correctly applied, BCG may be administered safely, and with confidence.

Objectives To evaluate the antitumor effect of the coincident administration of intravesical gemcitabine (Gem) plus bacillus Calmette-Guerin (BCG) in an orthotopic bladder cancer model. Methods We evaluated the cytotoxic effect of gemcitabine against MBT-2 cells in vitro. Orthotopic tumors were established by implanting MBT-2 cells into the bladder of syngeneic female C3H mice. Intravesical Gem administration was evaluated at various doses: 0 mg (control); 1, 2, 4, and 8 mg (n = 8 for each group). Next, a comparative evaluation of tumor growth among the control, Gem-alone, BCG-alone, and combined Gem + BCG groups was performed (n = 16 for each group). Therapy was administered at 3-day intervals starting on day 5 and repeated 6 times. To evaluate the proliferative activity among the groups, Ki-67 immunostaining of the tumor was performed. Results Gemcitabine exhibited a dose-dependent antitumor effect. Of the 8 mice in each group treated with a dose of 0, 1, 2, 4, or 8 mg of Gem, 1, 4, 4, 4, 5, and 4 mice failed to develop tumors and survived, respectively. The combination of Gem + BCG (54.1 ± 9.4 days) provided a significant survival advantage compared with BCG-alone (39.0 ± 16.4 days) ( P = .02). Ki-67 expression, representing tumor proliferation, was significantly lower in the combined Gem + BCG group than in the BCG-alone group ( P Conclusions Our results suggest that intravesical Gem + BCG treatment induces an enhanced antitumor effect against bladder tumors.

Thirty four bitches with defined histological forms of mammary carcinoma were studied post-mastectomy for over 100 weeks . They were randomized into 3 groups: (a) no further treatment ( 11 ), (b) placebo treatment ( 10 ), (c) intravenous BCG therapy ( 13 ). The mean survival time of the control groups was 24 weeks whereas for the treated group 100 weeks . This was significantly different (P 2 test ( χ 2 ).

Evidence from animal systems suggests that macrophages and thymus-dependent (T) lymphocytes mediate the antitumor effects of bacillus Calmette-Guerin (BCG). To evaluate the validity and applicability of these observations in man we have determined serum lysozyme activity (SLA) and enumerated “active” and total T cells in 10 consecutive patients with malignant melanoma during intralesional or adjuvant BCG therapy. Clinical responders showed a significant increase in the mean number of “active” T cells ( P P P