Case Conference February 14th 2018

14-Feb-2018, Divisi Ginekologi Onkologi RSCM

 

CLINICAL CONFERENCE

 

February 14^th, 2018

 

Mrs. T, 56 yo, P1A2, 4270618

 

Vulvar cancer of squamous cell carcinoma with abdominal mass (suspected ovarian neoplasm)

 

 

 

Case Description:

 

Patient complained of vaginal mass growing in a year. There was discharge from the laceration part of the mass. Vaginal bleeding was not very often. Patient was referred from Pelni Hospital to RSCM on 29^th January 2018.  Biopsy was done with result of squamous cell carcinoma.

 

Patient had history of uterus removing in Semarang due to tumor. Although it was said to be benign, there was no resume or pathology result from the previous operation.

 

 

 

Physical examination on January 31^st, 2018

 

General status:

 

CM, BP 128/85 mmHg, HR 72x/m, RR 20x/m, T 36⁰C

 

Head: pale conjungtiva (-/-), icteric sclera (-/-)

 

Axilla: lymph nodes (-/-)

 

Thorax: symmetric shape and movement of hemithorax

 

Lung: vesicular breath, wheezing (-/-), ronkhi (-/-)

 

Cardiac: murmur (-/-), gallop (-/-)

 

Abdomen: flat, there was cystic mass predominantly on the left side of the abdomen size approx. 10 x 8 cm, restricted mobilization, operation scar in the midline approx. 13 cm

 

Extremity: inguinal lymphadenopathy (-/-)

 

 

 

Gynecologic status:

 

Inspection: right side vulvar mass size 8 x 6 x 5 cm, infiltrated to orificium urethra externa but not to anus.

 

Speculum examination was not done, patient was in pain.

 

RVT: vulvar mass on the right side, size 8 x 6 x 5 cm, solid, immobile, pain on palpation, mass was infiltrated to 1/3 right lateral vagina, infiltrated to anterior vagina and the orificium urethra externa, no mass on vaginal stump, no mass on anus, no mass on rectum.

 

 

 

    

 

 

 

Pathology Anatomy of biopsy, January 31^st 2018

 

Clinical diagnosis: Vulvar cancer

 

Conclusion: Squamous cell carcinoma good-moderately differentiated

 

 

 

Ultrasound Examination, February 6^th 2018

 

Non-visual uterus and adnexa accordance with post hysterectomy and bilateral salpingo-oophorectomy.

 

Vaginal stump normal.

 

On both sides of vulva, there was solid mass, inhomogeneous with irregular border, enlarged into the vagina size 41 x 46 cm (right labia) and 29 x 20 mm (left labia), accordance with malignancy.

 

No enlargement of parailiac and paraaorta lymph nodes. No ascites. Liver and both kidneys normal.

 

Conclusion: Post HTSOB, malignant mass on bilateral vulva

 

 

 

 

 

 

 

 

 

 

 

    

 

Problem to be discussed

 

Is radiotherapy alone better than chemoradiation for patient with vulvar cancer stage II?

 

 

 

Clinical question in this case will be developed by PICO approach:

 

Patient	Vulvar cancer stage II
Intervention	Radiotherapy
Comparison	Chemoradiation
Outcome	Disease free survival Overall survival

 

 

 

METHODS

 

Search strategy

 

In order to answer the question above, we conduct a searching in PubMed site by using keywords “vulvar cancer stage II, chemo-radiation, radiation”. The search was conducted on Pubmed on February 13^th, 2018.

 

 

 

Search strategy used in Pubmed conducted February 13^th, 2018

 

Engine	Search Terms	Results
Pubmed	Vulvar cancer stage II AND radiation AND chemo-radiation	20

 

 

 

 

Vulvar cancer stage II AND radiation AND chemo-radiation

 

 

 

 

Reading full text

 

 

20

 

 

Filtering titles and abstracts

 

 

 

Pubmed

 

 

 

2 useful articles

 

   

 

 

 

 

 

 

 

Screening files

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 1. Flowchart of search strategy

 

 

 

Selection

 

From the articles, limitation was given for no abstract, not available in full text, not written in English, or articles which had no related titles. After the process, there were 2 articles appropriate for discussion.

 

 

 

 

 

Critical Appraisal

 

Article 1. A phase II trial of radiation therapy and weekly cisplatin chemotherapy for the treatment of locally-advanced squamous cell carcinoma of the vulva: a gynecologic oncology group study. Moore DH et. al. Gynecol Oncol. 2012 Mar;124(3):529-33.

 

Article 2. Impact of adjuvant chemotherapy with radiation for node-positive vulvar cancer: A National Cancer Data Base (NCDB) analysis. Gill BS et. al. Gynecol Oncol. 2015 Jun;137(3):365-72. 

 

 

 

A.      Are the Study Results Valid?                                                                             1^st Art           2^nd Art           

 

1.       Was there a representative and well-defined sample of patients at a similar point in the course of disease?	Yes	Yes
2.       Was follow-up sufficiently long and complete?	Yes	Yes
3.       Were objective and unbiased outcome criteria used?	Yes	Yes
4.       Was there adjustment for important prognostic factors?	Yes	Yes

 

B.      What Were the Results?

 

1.       How large is the likelihood of the outcome events in a specific period of time?	NA	NA
2.       How precise are the estimates of likelihood? (Consider 95% CI)?	NA	NA

 

C.      Can the Results be applied to your patients?

 

1.       Were the study patients similar to my own?	Yes	Yes
2.       Are the results useful for reassuring or counseling patients?	Yes	Yes
3.       Is the treatment feasible in my setting?	Yes	Yes

 

D.      CONCLUSIONS

 

1.       The results or recommendations are valid?	Yes	Yes
2.       The results clinically important?	Yes	Yes
3.       The results are relevant to my practice?	Yes	Yes

 

 

 

 

 

Discussion

 

Resection of the primary tumor of vulvar cancer and inguinofemoral lymphadenectomy may not be possible when nodes are fixed to the femoral vessels or other vital structures such as urethra and anus due to perioperative complications and poor quality of life. Therefore, chemoradiation and radiation become the primary treatment for patients with locally advanced vulvar cancer. Based upon limited data, patients with unresectable, locally advanced disease could be treated with chemoradiation to radiation therapy (RT) alone. Administration of weekly cisplatin 50 mg/m² concurrently with radiation and include the vulva, groin, and lymph nodes in the radiation fields is the choice. For patients who are not candidates for chemotherapy, primary RT alone is the choice.

 

The advantage of chemoradiation over RT alone was suggested in a study that utilized the United States National Cancer Database (NCDB). The study included more than 1700 women with node-positive, resected vulvar cancer (77 percent with up to three nodes involved) who subsequently were treated with adjuvant therapy. The adjuvant therapy was either RT or chemoradiation. Multivariate analysis showed that the addition of adjuvant chemotherapy was associated with a trend towards increased survival compared with adjuvant RT alone (HR 0.81, 95% CI 0.65-1.01). Most patients receiving chemotherapy in this study initiated it within one week of initiating radiotherapy.

 

There were several conditions which are considered appropriate for chemoradiation; include patients with:

 

ü  Anorectal, urethral, or bladder involvement (in an effort to avoid colostomy and urostomy)

 

ü  Disease that is fixed to the bone

 

ü  Gross inguinal or femoral node involvement (regardless of whether a debulking lymphadenectomy was performed)

 

In our current case, patient has had already mass infiltration into vagina and urethra.

 

 

 

Other evidence which showed the benefit of chemoradiation is shown in the Gynecologic Oncology Group (GOG) 205. The study included 58 patients with unresectable vulvar cancer underwent chemoradiation for locally advanced vulvar carcinoma. Of 40 patients who completed chemoradiation, 37 had a complete clinical response. Among these women, 34 underwent surgical biopsy, of whom 29 had a complete pathologic response (78 percent). Other data which is also considered to support this was GOG 101, which included 46 patients with unresectable, node-positive (N2 or N3) vulvar carcinoma. Thirty eight patients were able to undergo surgery after chemoradiation (those who had a complete response underwent surgical biopsy only). Of 37 who underwent a lymphadenectomy, 15 (40.5 percent) had no evidence of pathologic node involvement. At a median follow-up of 6.5 years, 12 patients (26 percent) were alive without evidence of disease.

 

 

 

Unfortunately, prospective trials comparing RT alone to chemoradiation in the treatment of vulvar cancer are not available. Indirect evidence should be used or extrapolated to this case. Some evidences even suggest that chemoradiation may be equivalent to surgery in patients with resectable disease. It is therefore providing a rationale for its use in patients for whom surgery is not an option. The study by Gill BS et. al. with NCB above has revealed a systematic review of three studies (one randomized) compared primary surgery with chemoradiation in women with locally advanced, primary squamous cell carcinoma. Compared with primary surgery, the use of chemoradiation alone resulted in no difference in overall mortality (hazard ratio [HR] 1.09, 95% CI 0.37-3.17); however, the wide confidence intervals suggest there are insufficient data to make a definitive conclusion, and all three studies were determined to be at moderate or high risk of bias.

 

 

 

Conclusion

 

Despite the lack of high-quality data in vulvar cancer, chemoradiation is an appropriate option in selected patients with locally advanced vulvar cancer. Chemoradiation compared with radiation alone has led to decreased recurrence rates and has been associated with a survival benefit in cervical cancer.

 

 

 

 

 

 

 

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