This document discusses chemotherapy options for metastatic bladder cancer. It notes that the prognosis remains poor with a median survival of 14 months. It reviews response rates of single agents like cisplatin, methotrexate, and doxorubicin. It then discusses combination regimens like MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), noting response rates of around 50% and median survival of approximately 12 months based on several studies. Larger phase 3 trials found MVAC improved median survival compared to cisplatin or cisplatin/cyclophosphamide regimens.
Surgery vs IMRT for High Risk Prostate Cancer Debate - ACRO 2015drewzer
American College of Radiation Oncology Annual Meeting, Alexandria, Virginia. Drew Moghanaki, MD, MPH, Hunter Holmes McGuire Veterans Affairs Medical Center, Virginia Commonwealth University
Surgery vs IMRT for High Risk Prostate Cancer Debate - ACRO 2015drewzer
American College of Radiation Oncology Annual Meeting, Alexandria, Virginia. Drew Moghanaki, MD, MPH, Hunter Holmes McGuire Veterans Affairs Medical Center, Virginia Commonwealth University
Robert Dreicer, MD, MS, MACP, FASCO, Michael S. Cookson, MD, MMHC, Oliver Sartor, MD, and Neal D. Shore, MD, FACS, prepared useful practice aids pertaining to prostate cancer management for this CME activity titled "Science and Stories: Navigating the Prostate Cancer Landscape - Urologists at the Intersection of Emerging Evidence and Patient Centric Care." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2JFhjpM. CME credit will be available until June 26, 2019.
Controversies in the management of rectal cancersAjeet Gandhi
Management of rectal cancers have undergone a huge paradigm shift over the last decade. One the one hand, it has opened up new avenues; it also has thrown up new challenges and controversies
Robert Dreicer, MD, MS, MACP, FASCO, Michael S. Cookson, MD, MMHC, Oliver Sartor, MD, and Neal D. Shore, MD, FACS, prepared useful practice aids pertaining to prostate cancer management for this CME activity titled "Science and Stories: Navigating the Prostate Cancer Landscape - Urologists at the Intersection of Emerging Evidence and Patient Centric Care." For the full presentation, monograph, complete CME information, and to apply for credit, please visit us at http://bit.ly/2JFhjpM. CME credit will be available until June 26, 2019.
Controversies in the management of rectal cancersAjeet Gandhi
Management of rectal cancers have undergone a huge paradigm shift over the last decade. One the one hand, it has opened up new avenues; it also has thrown up new challenges and controversies
Long Term Effects of Using Medicinal Mushroom Preparations in Human Colorecta...Neven Jakopovic
52 patients with bowel cancer and 89 with breast cancer used medicinal mushroom extracts from Myko San company with standard oncological treatments. In this cohort study, lasting from 2005-2010, we analysed the long term effects of using medicinal mushroom products in cancer patients.
While medicinal mushrooms are not 'magic bullets', this study provides unquestionable evidence of the benefits of their use as supportive therapy in cancer patients, leading to significantly improved outcomes.
This work was presented by Neven Jakopovic at the 6th International Medicinal Mushroom Conference in Zagreb, Croatia, in 2011.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
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2. 1.5-2% of all malignant neoplasms in males in
India
Second commonest urologic malignancy
after prostate cancer in india.
More common in urban than rural areas
9. Rationale for Neoadjuvant Therapy
Give systemic therapy when the pelvic blood
supply is intact
in vivo chemo-sensitivity trial
Deal with micrometastatic disease
immediately
Patient is fitter and more able to tolerate
chemotherapy
10.
11. Neoadjuvant chemotherapy-CMV
EORTC/MRC trial (European) –Using CMV
976 patients randomized to CMV vs no chemotherapy
Definitive management of primary either cystectomy or RT
No subgroup analysis done to compare cystectomy and RT
groups
With a median follow-up of eight years, neoadjuvant CMV was
associated with a reduction in the risk of death compared to
local treatment alone (HR 0.84, 95% CI0.72-0.99) . This
corresponds to an absolute improvement in OS at 10 years of
six percent (30 to 36 percent).
Lancet 354 (9178): 533-40, 1999
12. Neoadjuvant Chemotherapy
INT-0800(American) study-MVAC
Confirmed results of MRC study
317 patients with T2 to T4a disease
Randomized to 3 cycles of neoadjuvant MVAC prior to
cystectomy or cystectomy alone
Improved median survival by almost 3 years (77 months
vs 46 months)
Decreased risk of bladder cancer specific death by 25%
Improved OS by 5% (p=0.06)
Grossman et al, N Engl J Med 349 (9): 859-66, 2003
14. Neoadjuvant Chemotherapy
INT-0080 continued
Of long term survivors 85% had a complete
pathologic response at the time of cystectomy
cPR rates
38% in MVAC group
15% in surgery alone group (post TURBT)
p=0.001
Patients with T3 and T4 disease achieved the
greatest survival benefit
15. Gem /Cis as NACT
Hussein Khaled and his colleagues at the Egyptian Bladder Cancer
Cooperative in Cairo, Egypt-gemcitabine/cisplatin regimen as
neoadjuvant chemotherapy for invasive bladder cancer
phase 3 trial, 114 patients were randomized to receive either
cystectomy alone (56 patients), or to 3 cycles of
gemcitabine/cisplatin preoperatively (58 patients).
Patients with a complete response received 3 additional cycles
followed by radiation treatment (68 Gy/7 weeks). Patients who were
subsequently downstaged to T2-T3 went on to surgery and received
an additional 3 cycles of the regimen postoperatively. Patients with
stable disease or disease progression following chemotherapy went
on to surgery immediately
16. reported an overall response of 56% (30% complete
response [CR] and 25% partial response [PR]), and
bladder preservation was possible in 22% of those
patients who had a CR.
They also noted a trend toward increased 1-year survival
in the chemotherapy patients relative to cystectomy-
alone patients (69% vs 54%, P = .9)
17. GC Vs MVAC as NACT
GC and MVAC have only been compared in retrospective
studies
These studies suggest it results in similar rates of pCR and
survival outcomes .
Despite the lack of prospective data, GC is administered in this
setting based on data from studies performed in patients with
metastatic urothelial carcinoma, which show six cycles of GC
result in a better toxicity profile compared to MVAC without a
major difference in OS.
Yeshchina O, et al. Relative efficacy of perioperative GC Vs MVAC in the management of locally advanced urothelial carcinoma of the bladder. Urology 2012; 79:384.
18. Neoadjuvant Chemotherapy-Meta-
analysis(3)
Meta-analyses (1)
Advanced Cancer Meta-analysis Collaboration
Included 2688 patients from 10 randomized trials
(did not include INT-0080)
Showed increased overall survival benefit of 5% at
5 yrs p=0.016 when neoadjuvant platinum based
combination chemotherapy used
Not significant if only single agent cisplatin trials
were included
Advanced Bladder Cancer Meta-analysis Collaboration.: Neoadjuvant
chemotherapy in invasive bladder cancer: a systematic review and meta-analysis.
Lancet 361 (9373): 1927-34, 2003
19. Neoadjuvant Chemotherapy
Canadian Meta-analysis(2)
Winquist et al
2605 patients in 11 trials with stage II or stage III
disease
2-4 cycles of neoadjuvant chemo
Improved OS by 6.5% p=0.006
Mortality due to chemotherapy 1.1%
Winquist E, et al, J Urol. 2004 Feb;171(2 Pt 1):561-9
20. Neoadjuvant Chemotherapy
Advanced Bladder Cancer Meta-analysis
collaboration(3)
Included 11 trials with 3005 patients
Included 98% of all known patients in randomized
trials using cisplatin based combination
chemotherapy
Improved OS by 5%; p=0.003
Decreased risk of death by 14%
Advanced Bladder Cancer (ABC) Meta-analysis Collaboration.
Eur Urol. 2005 Aug;48(2):202-5
21. Cochrane review --2008
Platinum based combination chemotherapy showed a
significant benefit on overall survival with a combined
hazard ratio (HR) 0.86 (95% CI 0.77 to 0.95, P =0.003);
14% reduction in the risk of death;
5% absolute benefit at 5 years (95% CI 1% to 7%); overall
survival increased from 45% to 50%.
This effect was observed irrespective of the type of local
treatment and did not vary between subgroups of
patients.
22. Cochrane review –2008-Contd
The HR for all trials, including those that used single-
agent cisplatin, tended to favour neoadjuvant
chemotherapy (HR= 0.89, 95% CI 0.81 to 0.98, P = 0.022).
Although platinum based combination chemotherapy
was beneficial, there was no clear evidence to support
the use of single-agent platinum, indeed there was
significant difference in the effect between these groups
of trials (P = 0.029)
23. Conclusions-NACT
Neoadjuvant chemotherapy — For patients undergoing
neoadjuvant chemotherapy, cisplatin-based combination
regimens should be used.
However, the ideal neoadjuvant chemotherapy regimen
is not known.
Commonly employed regimens administered in the
neoadjuvant settinginclude:MVAC,CMV,GC
24. Doses
MVAC — Methotrexate (30 mg/m2 on days 1, 15, and 22),
vinblastine (3mg/m2 on days 2, 15, and 22), doxorubicin (30
mg/m2 on day 2), and cisplatin (70 mg/m2 on day 2)
administered every 28 days for three cycles .
CMV — Methotrexate (30 mg/m2) and vinblastine (4
mg/m2) on days 1 and 8 plus cisplatin (100 mg/m2 on day
2), with folinic acid (15 mg every six hours for four doses) on
days 2 and 9, repeated every 28 days forthree cycles .
GC — Gemcitabine (1000 mg/m2 on days 1, 8, 15) plus
cisplatin (70mg/m2 on day 2) every 28 days for a maximum
of six cycles .
25. Adjuvant Chemotherapy -RATIONALE
For patients with muscle invasive bladder cancer,
cystectomy alone is associated with a 50 to 65 percent
overall survival rate, which may be as high as 80 percent in
patients who have pT2 disease .
However, patients with locally advanced disease are at risk
for worse outcomes. The five-year survival rate in patients
with invasion beyond the bladder muscle is approximately 40
percent, while the survival for patients with lymph node
involvement does not exceed 10 percent.
26. Given the benefit of chemotherapy in the neoadjuvant
setting and the poor prognosis of patients following
surgical resection, adjuvant chemotherapy is often used in
patients with high-risk bladder cancer.
Although this rationale provides the justification for the
use of adjuvant chemotherapy, the available data from
randomized trials provide little conclusive evidence that
adjuvant therapy improves survival outcomes.
In addition, approximately 30 percent of patients
experience complications following radical cystectomy
that preclude them from receiving adjuvant
chemotherapy .
27.
28. Spanish Oncology GU Group
Trial 99/01
The Spanish Oncology Genitourinary Group trial 99/01 planned
to randomly assign 340 patients with T3-T4 or node positive
disease to treatment using four cycles of paclitaxel, gemcitabine,
and cisplatin (PGC) or observation .
However, the trial was terminated in 2007 because of poor
accrual after only 142 patients were enrolled.
The preliminary results of this trial were presented at the 2010
American Society of Clinical Oncology (ASCO) meeting. At a
median follow-up of 51 months, adjuvant PGC resulted in a
significant increase in overall survival (OS) at five years compared
to no chemotherapy (60 versus 30 percent, hazard ratio [HR]
0.44).
Paz-Ares LG, Randomized phase III trial comparing adjuvant PGC to observation in patients with
resected invasive bladder cancer: J Clin Oncol 2010; 28:18s
29. Adj CT-Italian trial-Using GC
Gemcitabine plus cisplatin (GC) -194 patients with pT2
(grade 3) or pT3-4, N0-2 urothelial bladder carcinoma were
randomly assigned to four cycles of GC or observation.
Patients on the GC arm were also randomly assigned
receive gemcitabine 1000 mg/m2
days 1, 8 and 15 and
cisplatin 70 mg/m2
day 2 or gemcitabine as above plus
cisplatin 70 mg/m2
day 15, every 28 days .
For patients on observation, GC was administered at the
time of disease progression.
Cognetti F, Adjuvant chemotherapy with GCversus chemotherapy at relapse in patients with muscle-invasive bladder
cancer submitted to radical cystectomy: an Italian, multicenter, randomized phase III trial. Ann Oncol 2012; 23:695
30. The trial was prematurely closed due to poor accrual.
At a median follow-up of 35 months, there was no
difference in either overall survival (HR 1.29, 95% CI 0.84-
2.00) or disease-free survival (HR 1.08, 95% CI 0.73-1.59)
compared to observation
However, the study was underpowered to show the
impact of treatment on either endpoint.
31. Adj CT - EORTC Trial
EORTC Trial — A very different phase III study
which aimed to randomly assign 660 patients to
observation or treatment with adjuvant
chemotherapy (either methotrexate, vincristine,
doxorubicin, cyclophosphamide [M-VAC] or High
Dose M-VAC [HD-MVAC] or GC at the discretion
of the treating physician).
After enrollment of 248 patients, the trial was
closed due to slow accrual (though this surpasses
the accrual of patients in other contemporary
trials).
33. Summary of these trials
Multiple trials
Small patient numbers ranging from 49-102
Two trials suggest survival benefit
Skinner et al. J Urol 1991
91 patients
Included T3-4 or node positive patients
Randomized to 4 cycles of cis/doxo/cyclo or observation
Median survival
4.3 yrs chemo p=0.006
2.4 yrs observation
Criticized - ? selection bias:
91 of 498 patients screened were eligible
Skinner DG et al, J Urol. 1991 Mar;145(3):459-64
34. Adjuvant chemotherapy-Meta-analysis
Meta analysis-
Cochrane Collaboration 2006
491 pts. from 6 trials
Power limited
Small numbers
Impact of trials stopped early
Patients not receiving allocated rx
Patients not receiving salvage chemotherapy
Showed a relative decrease in death of 25% in favour of
adjuvant chemotherapy (p=0.02)
Absolute survival benefit: 9%
Cochrane Database Syst Rev. 2006 Apr 19;(2):CD006018
36. Conclusion--Compare and Contrast
Neoadjuvant
Deals with micromets
sooner
Best evidence of
benefit
Concern re: delay in
surgery
? Increased surgical
complications
Is benefit worth it?
Adjuvant
Treats only the highest
risk pts.
No delay in local Rx
Evidence of benefit is
weaker
Delays in healing may
preclude giving
therapy
Is benefit worth it?
38. Typically, bladder cancer recurs in the pelvic
lymph nodes and distant sites
Despite the fact that bladder cancer is
chemosensitive, the prognosis of patients
with metastatic disease remains poor, with a
median survival of 14 months and a 5-year
survival rate of 15%
40. CHEMOTHERAPY
IN METASTATIC BLADDER CANCER
• Cisplatin + Methotrexate
- CM
• Cisplatin + Methotrexate + Vinblastine
- CMV
• Methotrexate + Vinblastine + Adriamycin + Cisplatin
- MVAC
“Old” drug combinations
41.
42. MVAC
IN METASTATIC BLADDER CANCER
• Sternberg et al., 1985, 1989
– overall response rate 72%
– CR rate 25% + 11% (surgery)
– median survival 13 months
43. MVAC
IN METASTATIC BLADDER CANCER
• Memorial Sloan-Kettering Cancer Center
5 studies with 194 evaluable patients
– overall response rate 67%
– CR rate 24%
– median survival 14.8 months
• Other studies
– overall response rate about 50%
– CR rate about 15%
– median survival about 12 months
44. MVAC
IN METASTATIC BLADDER CANCER
Phase III studies
• Logothetis et al., 1990
– MVAC > CISCA
– MS 82 vs 40 weeks
• Loehrer et al., 1992
– MVAC > Cisplatin
– MS 12.6 vs 8.7 m
45. MVAC - ERA
IN METASTATIC BLADDER CANCER
• MVAC is associated with substantial toxicities and
a toxic death rate of 3-4%
• Thus, a need for alternative regimens with
superior efficacy and/or decreased toxicity was
identified
47. PACLITAXEL ALONE
IN METASTATIC BLADDER CANCER
Study Prior
CT
Patients
(n)
OR%
(CR%)
Survival
(months)
Papamichael,
1997
Y 14 7% (0%) NR
Vaughn,
2002
Y 31 10% (0%) 7.2
Dreicer,
1996
Y/N 9 56% (0%) NR
Roth,
1994
N 26 42% (27%) 8.4
48. DOCETAXEL ALONE
IN METASTATIC BLADDER CANCER
Study Prior CT Patients
(n)
OR%
(CR%)
Survival
(months)
McCaffrey,
1997
Y 30 13%
(0%)
9
de Wit,
1998
N 29 31%
(14%)
NR
51. DOCETAXEL + CISPLATIN vs MVAC
IN METASTATIC BLADDER CANCER
Drug regimen Overall response Median survival
D + C 37% 9.3 months
MVAC 54% 14.2 months
N=220
Bamias et al., 2004
59. • GC provides a similar survival advantage to MVAC with a
better safety profile and tolerability. This better risk benefit
ratio should change the standard of care for patients with
locally advanced and metastatic TCC from MVAC to GC
Conclusion
von der Maase et al.
J Clin Oncol 18:3068-3077, 2000
60. Second-line Chemotherapy
No standard second-line chemotherapy exists
for patients with bladder cancer who progress
on the standard first-line platinum-based
treatment with MVAC or GC
Various single agents, including paclitaxel,
docetaxel, gemcitabine, ifosfamide,
oxaliplatin, and vinflunine, have been studied
in this setting with modest response rates of
less than 20%.
61. Pemetrexed, a multitargeted antifolate, is
also an active agent in the second-line setting
The Hoosier Oncology Group37 study
demonstrated a response rate of 28% and a
median survival of 9.6 months
Albumin-bound paclitaxel is another agent
that has shown promising activity in a phase II
study in 48 patients progressing on
platinumbased chemotherapy
62. Eribulin has demonstrated response rates of
40% as a single agent in bladder cancer
it is not renally excreted and is being studied
in patients with renal dysfunction
63. Novel Agents in Bladder Cancer
Trastuzumab
Tyrosine kinase inhibitor (TKI) Gefitinib ,
Erlotinib
VEGF TKI Sunitinib, Pazopanib
Dovitinib is an oral inhibitor of VEGFR and
FGFR and is being evaluated in combination
with GC or carboplatin in bladder cancer
64. Conclusions
Bladder cancer is a chemosensitive disease,
and systemic chemotherapy plays a role in its
management
Cisplatin-based combination chemotherapy
prolongs survival in the metastatic setting,
and methotrexate,vinblastine, doxorubicin,
and cisplatin or combination
gemcitabine/cisplatin is the current standard
of care
65. carboplatin should not be substituted for
cisplatin in fit patients, it may be considered
in those who are ineligible for cisplatin
No approved second-line chemotherapy for
metastatic bladder cancer exists, and
response rates with available agents are
variable
66. The role of neoadjuvant cisplatin-based
combination chemotherapy has been
extensively evaluated and is associated with a
modest but significant survival benefit
The achievement of pathological complete
response (pT0) with neoadjuvant
chemotherapy has strong prognostic
significance and may represent an alternate
clinical end point for clinical trials
67. Although robust data are lacking for the use
of chemotherapy in the adjuvant setting after
cystectomy, it may be considered in patients
who are at high risk for relapse
Unlike other solid tumors, targeted therapy is
not well established in bladder cancer, and a
critical need exists to develop novel agents
that complement or are an alternative to
conventional chemotherapies
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