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[51]
survival. The group of La Princesa University Hospital (Madrid, unfortunately is not reported in the RCT. As mentioned above, in
[52]
Spain) analyzed only END patients who were pN0, which the meta-analysis of Fasunla et al. END significantly reduces the
obviously resulted in better overall survival in END patients. risk of disease specific deaths.
Three studies reported a significantly better disease-free survival
[1]
in the END arm. [6,13,15] Flach et al. presents a survival analysis of a large series of
patients with T1-T2 cancer of the mobile tongue or floor of mouth
Fasunla et al. systematically reviewed the available literature with a wait and scan follow-up policy of the neck with regular
[52]
and performed a meta-analysis on the existing randomized ultrasound guided fine needle aspiration cytology (USgFNAC).
controlled clinical trials which compared END with observation The 5-year disease specific survival (DSS) and overall survival (OS)
(and therapeutic neck dissection only when lymph node of “wait and scan” policy (W&S) patients were 94.2% and 81.6%,
metastasis were detected) in early OSCC patients. Only four respectively, and these rates were comparable to those of END
randomized clinical trials with a total of 283 patients were eligible patients. The most important finding is that in W&S patients
for inclusion in this meta-analysis. Although the data used in that with delayed metastases the 5-year DSS and OS were similar
meta-analysis were from different parts of the world, between to END patients with proven metastases in the neck dissection
study heterogeneity of the relative risk of disease specific specimen: 80.0% and 62.8% to 81.3% and 64.2%, respectively. In
death in the trials were tested and no statistically significant order to justify an observation policy, survival rates of patients
difference were found. This meta-analysis showed that END with delayed metastases in a W&S policy should not be worse
significantly reduced the risk of disease specific death: fixed- than rates of END patients with nodal metastases in the neck
effects model RR = 0.57 [95% confidence interval (CI) 0.36- dissection specimen. In the above mentioned series the patients
0.89; P = 0.014] and random-effects model RR = 0.59 (0.37- who developed delayed metastases (27.8%) did not have worse
0.96; P = 0.034). [52] survival rates (DSS 80.0%, OS 62.8%) as compared to END patients
with nodal metastases in the neck dissection specimen (DSS
D’Cruz and Dandekar from Tata Memorial Center (Mumbai, India) 81.3%, OS 64.2%), also when corrected for confounding factors.
[53]
performed a critical appraisal of this meta-analysis which revealed Moreover, with regard to the total study groups after correction
“some caveats that need careful consideration before the findings for confounding no significant difference in survival between
can be accepted”. They pointed out the poor follow-up in one of W&S and END patients was found and survival rates were
the included studies that resulted in a large number of patients with comparable to the reported rates in literature. Out of the W&S
[4-6]
advanced neck recurrences and low salvage rates. Finally, they patients, 72.2% did not develop lymph node metastases during
emphasized the need for meticulous follow-up patients on the follow-up, meaning that they were saved from END with good
[53]
observation arm. The same group analyzed their series of 359 survival rates (DSS 99.4%, OS 89.1%). Although, DSS in the W&S
patients with early oral cancer, found no difference in disease group was significantly different between pT1 and pT2 tumors,
specific survival between END and observation and elaborated pT2 tumors still had a 5-year DSS of 88.6%, which resembles the
[15]
the need for a large randomized controlled clinical trial (RCT). survival rates of END patients.
The Head and Neck Disease Management group of Tata
Memorial Centre performed such a trial, enrolled 596 patients Tsang et al. stated that “wait and scan” would not be effective
[56]
and reported the results of the first 500 patients. The conclusion in pT2 tumors, but that conclusion was based on a 5-year DSS
was that among patients with early stage OSCC, END results in of 46% for pT2 tumors. These authors assumed that the delayed
higher rates of overall and disease free survival than observation lymph node metastases were missed by preoperative USgFNAC.
with therapeutic neck dissection in patients in whom lymph In a “wait and scan” policy, the diagnostic method should
node metastases are detected during follow-up. [54] be highly sensitive. This is dependent on the cut off level for
aspiration and of the expertise of the radiologist. [57-59] Almost all
The group of the Tata Memorial Centre had chosen overall patients with delayed metastases underwent a modified radical
survival as primary endpoint and disease free survival as neck dissection and 90.6% needed adjuvant radiotherapy. Since
secondary endpoint for their RCT. END resulted in an improved they also found metastases in level IV, they would recommend
3-year overall survival rate (80%; 95% CI 74-86) as compared with selective neck dissection of level I-IV in case of delayed lymph
observation and therapeutic neck dissection (68%; 95% CI 61-74): node metastases, although Wensing et al. suggested selective
[60]
hazard ratio of death 0.64 (95% CI 0.45-0.92; P = 0.01). Patients neck dissection of level I-III.
in the END group had a higher disease free survival than those in
[54]
the observation group (79% vs. 46%, P < 0.001). It is not surprising Borgemeester et al. compared the overall survival in head
[57]
that END improves the regional control rate because development and neck squamous cell carcinoma patients with a clinically N0
of lymph node metastases during observation of the neck should neck who underwent END or close observation using regular
be taken into account as an inevitable consequence of the adopted USgFNAC during follow-up. Survival in the OSCC patients of
strategy. Therefore, this disease free survival is a useful outcome the close observation group was not different from the END
measure of diagnostic work-up but not a reliable outcome measure group: 90% and 81% after 3 years and 79% and 75% after 5
in comparing END and observation of the neck. years, respectively. Nieuwenhuis et al. showed that by using
[61]
USgFNAC pretreatment and during follow-up 79% of the delayed
Ganly et al. reported on a series on 216 cT1-T2N0 patients metastases could be salvaged resulting in a regional control rate
[55]
treated with or without END and found a 5-year disease specific, of 88%.
overall and disease free survival of 86%, 79% and 70%, respectively.
[14]
Disease specific survival is probably the most clinically meaningful Yuen et al. performed a prospective multicenter randomized
endpoint for measuring an eventual benefit of END, but trial in 71 T1-T2 oral cancer patients with cN0 necks
Plast Aesthet Res || Volume 3 || May 25, 2016 169